U.S. patent number 7,658,196 [Application Number 11/739,778] was granted by the patent office on 2010-02-09 for system and method for determining implanted device orientation.
This patent grant is currently assigned to Ethicon Endo-Surgery, Inc.. Invention is credited to Daniel F. Dlugos, Annie L. Ferreri, William L. Hassler, Jr., David N. Plescia.
United States Patent |
7,658,196 |
Ferreri , et al. |
February 9, 2010 |
System and method for determining implanted device orientation
Abstract
A system is operable to detect the orientation of an implant
component. The system comprises an implantable component, an
external component, and a logic component. The implantable
component comprises a first coil operable to transmit a first
signal having a phase. The external component comprises a second
coil operable to transmit a second signal having a phase. The logic
component is operable to compare the phase of the first signal with
the phase of the second signal. The logic component is further
configured to determine an orientation of the first coil relative
to the second coil based on a comparison of the phase of the first
signal with the phase of the second signal. The system may be used
to determine the orientation of an injection port in an implanted
gastric band system. The system may alternatively be used in a
variety of other types of systems.
Inventors: |
Ferreri; Annie L. (Loveland,
OH), Dlugos; Daniel F. (Middletown, OH), Plescia; David
N. (Cincinnati, OH), Hassler, Jr.; William L. (Carlsbad,
CA) |
Assignee: |
Ethicon Endo-Surgery, Inc.
(Cincinnati, OH)
|
Family
ID: |
39590301 |
Appl.
No.: |
11/739,778 |
Filed: |
April 25, 2007 |
Prior Publication Data
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Document
Identifier |
Publication Date |
|
US 20070213837 A1 |
Sep 13, 2007 |
|
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
|
11369682 |
Mar 7, 2006 |
|
|
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|
11065410 |
Feb 24, 2005 |
|
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Current U.S.
Class: |
128/899;
600/37 |
Current CPC
Class: |
A61B
5/06 (20130101); A61F 5/0079 (20130101); A61B
34/20 (20160201); A61B 90/98 (20160201); A61M
39/0208 (20130101); A61F 5/0053 (20130101); A61B
5/067 (20130101); A61B 5/062 (20130101); A61B
90/36 (20160201); A61B 2034/107 (20160201); A61M
2205/3523 (20130101); A61B 17/1355 (20130101); A61M
2205/587 (20130101); A61B 2017/00557 (20130101); A61B
2034/2051 (20160201); A61B 90/39 (20160201); A61B
2034/2048 (20160201); A61M 2039/0238 (20130101); A61B
34/25 (20160201); A61B 17/12009 (20130101); A61B
2090/064 (20160201); A61M 2039/0226 (20130101); A61M
2205/3331 (20130101); A61M 2205/3327 (20130101) |
Current International
Class: |
A61B
19/00 (20060101) |
Field of
Search: |
;128/897-899
;600/29-32,37,593 ;604/27-28,909
;606/139-141,151,157,201-203,213,228 ;607/41 |
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3908461 |
September 1975 |
Turpen |
3908721 |
September 1975 |
McGahey et al. |
3910087 |
October 1975 |
Jones |
3912168 |
October 1975 |
Mullins et al. |
3912304 |
October 1975 |
Abildgaard et al. |
3918286 |
November 1975 |
Whitehead |
3918291 |
November 1975 |
Pauly et al. |
3920965 |
November 1975 |
Sohrwardy et al. |
3921682 |
November 1975 |
McGahey et al. |
3922951 |
December 1975 |
Linsinger et al. |
3923060 |
December 1975 |
Ellinwood, Jr. |
3924635 |
December 1975 |
Hakim et al. |
3928980 |
December 1975 |
Ganzinotti et al. |
3929175 |
December 1975 |
Coone |
3930682 |
January 1976 |
Booth |
3930852 |
January 1976 |
Tanaka et al. |
3936028 |
February 1976 |
Norton et al. |
3939823 |
February 1976 |
Kaye et al. |
3940122 |
February 1976 |
Janzen |
3940630 |
February 1976 |
Bergonz |
3942299 |
March 1976 |
Bory et al. |
3942382 |
March 1976 |
Hok |
3942536 |
March 1976 |
Mirowski et al. |
3943915 |
March 1976 |
Severson |
3945704 |
March 1976 |
Kraus et al. |
3946613 |
March 1976 |
Silver |
3946615 |
March 1976 |
Hluchan |
3946724 |
March 1976 |
La Balme et al. |
3948141 |
April 1976 |
Shinjo et al. |
3949388 |
April 1976 |
Fuller |
3953289 |
April 1976 |
Costes et al. |
3954271 |
May 1976 |
Tredway, Sr. |
3958558 |
May 1976 |
Dunphy et al. |
3960142 |
June 1976 |
Elliott et al. |
3961425 |
June 1976 |
Swanson et al. |
3961646 |
June 1976 |
Schon |
3962895 |
June 1976 |
Rydell |
3962921 |
June 1976 |
Lips |
3963019 |
June 1976 |
Quandt |
3964485 |
June 1976 |
Neumeier |
3964770 |
June 1976 |
Abildgaard et al. |
3967737 |
July 1976 |
Peralta et al. |
3968473 |
July 1976 |
Patton et al. |
3968594 |
July 1976 |
Kawakami |
3972320 |
August 1976 |
Kalman |
3973753 |
August 1976 |
Wheeler |
3973858 |
August 1976 |
Poisson et al. |
3974655 |
August 1976 |
Halpern et al. |
3974865 |
August 1976 |
Fenton et al. |
3976278 |
August 1976 |
Dye et al. |
3977391 |
August 1976 |
Fleischmann |
3980871 |
September 1976 |
Lindstrom et al. |
3982571 |
September 1976 |
Fenton et al. |
3983948 |
October 1976 |
Jeter |
3985133 |
October 1976 |
Jenkins et al. |
3987860 |
October 1976 |
Jabsen |
3989005 |
November 1976 |
Bowler, Jr. et al. |
3991749 |
November 1976 |
Zent |
3992948 |
November 1976 |
D'Antonio et al. |
3993149 |
November 1976 |
Harvey |
3996927 |
December 1976 |
Frank |
3996962 |
December 1976 |
Sutherland |
4003141 |
January 1977 |
Le Roy |
4005282 |
January 1977 |
Jennings |
4005593 |
February 1977 |
Goldberg |
4006735 |
February 1977 |
Hittman et al. |
4009375 |
February 1977 |
White et al. |
4009591 |
March 1977 |
Hester |
4010449 |
March 1977 |
Faggin et al. |
4014319 |
March 1977 |
Favre et al. |
4014321 |
March 1977 |
March |
4016764 |
April 1977 |
Rice |
4017329 |
April 1977 |
Larson |
4018134 |
April 1977 |
Linsinger |
4022190 |
May 1977 |
Meyer |
4024864 |
May 1977 |
Davies et al. |
4025912 |
May 1977 |
Rice |
4026276 |
May 1977 |
Chubbuck |
4027661 |
June 1977 |
Lyon et al. |
4031899 |
June 1977 |
Renirie |
4036775 |
July 1977 |
Trautvetter et al. |
4039069 |
August 1977 |
Kwan et al. |
4041954 |
August 1977 |
Ohara et al. |
4042504 |
August 1977 |
Drori et al. |
4045345 |
August 1977 |
Drori et al. |
4047296 |
September 1977 |
Ishida et al. |
4047851 |
September 1977 |
Bender |
4048494 |
September 1977 |
Liesting et al. |
4048879 |
September 1977 |
Cox |
4049004 |
September 1977 |
Walters |
4051338 |
September 1977 |
Harris, III |
4052991 |
October 1977 |
Zacouto et al. |
4055074 |
October 1977 |
Thimons et al. |
4055175 |
October 1977 |
Clemens et al. |
4056854 |
November 1977 |
Boretos et al. |
4058007 |
November 1977 |
Exner et al. |
4062351 |
December 1977 |
Hastwell et al. |
4062354 |
December 1977 |
Taylor et al. |
4062360 |
December 1977 |
Bentley |
4063439 |
December 1977 |
Besson et al. |
4064882 |
December 1977 |
Johnson et al. |
4070239 |
January 1978 |
Bevilacqua |
4072047 |
February 1978 |
Reismuller et al. |
4073292 |
February 1978 |
Edelman |
4075099 |
February 1978 |
Pelton et al. |
4075602 |
February 1978 |
Clothier |
4077072 |
March 1978 |
Dezura |
4077394 |
March 1978 |
McCurdy |
4077405 |
March 1978 |
Haerten et al. |
4077882 |
March 1978 |
Gangemi |
4078620 |
March 1978 |
Westlake et al. |
4080653 |
March 1978 |
Barnes, Jr. et al. |
4084752 |
April 1978 |
Hagiwara et al. |
4086488 |
April 1978 |
Hill |
4087568 |
May 1978 |
Fay et al. |
4088417 |
May 1978 |
Kosmowski |
4089329 |
May 1978 |
Couvillon, Jr. et al. |
4090802 |
May 1978 |
Bilz et al. |
4092719 |
May 1978 |
Salmon et al. |
4092925 |
June 1978 |
Fromson |
4096866 |
June 1978 |
Fischell |
4098293 |
July 1978 |
Kramer et al. |
4103496 |
August 1978 |
Colamussi et al. |
4106370 |
August 1978 |
Kraus et al. |
4107689 |
August 1978 |
Jellinek |
4107995 |
August 1978 |
Ligman et al. |
4108148 |
August 1978 |
Cannon, III |
4108575 |
August 1978 |
Schal et al. |
4109148 |
August 1978 |
Jaulmes et al. |
4109518 |
August 1978 |
Dooley et al. |
4109644 |
August 1978 |
Kojima |
4111056 |
September 1978 |
Mastromatteo |
4111629 |
September 1978 |
Nussbaumer |
4114424 |
September 1978 |
Johnson |
4114603 |
September 1978 |
Wilkinson |
4114606 |
September 1978 |
Seylar |
4120097 |
October 1978 |
Jeter |
4120134 |
October 1978 |
Scholle |
4121635 |
October 1978 |
Hansel |
4123310 |
October 1978 |
Varon et al. |
4124023 |
November 1978 |
Fleischmann et al. |
4127110 |
November 1978 |
Bullara |
4130169 |
December 1978 |
Denison |
4131596 |
December 1978 |
Allen |
4133355 |
January 1979 |
Mayer |
4133367 |
January 1979 |
Abell |
4135509 |
January 1979 |
Shannon |
4140131 |
February 1979 |
Dutcher et al. |
4141348 |
February 1979 |
Hittman |
4141349 |
February 1979 |
Ory et al. |
4143661 |
March 1979 |
LaForge et al. |
4146029 |
March 1979 |
Ellinwood, Jr. |
4147161 |
April 1979 |
Ikebe et al. |
4148096 |
April 1979 |
Haas et al. |
4149423 |
April 1979 |
Frosch et al. |
4151823 |
May 1979 |
Grosse et al. |
4153085 |
May 1979 |
Adams |
4156422 |
May 1979 |
Hildebrandt et al. |
4160448 |
July 1979 |
Jackson |
4160971 |
July 1979 |
Jones et al. |
4166469 |
September 1979 |
Littleford |
4167304 |
September 1979 |
Gelbke |
4167952 |
September 1979 |
Reinicke |
4168567 |
September 1979 |
Leguy et al. |
4170280 |
October 1979 |
Schwarz |
4171218 |
October 1979 |
Hoshino et al. |
4173228 |
November 1979 |
Van Steenwyk et al. |
4183124 |
January 1980 |
Hoffman |
4183247 |
January 1980 |
Allen et al. |
4185641 |
January 1980 |
Minior et al. |
4186287 |
January 1980 |
Scott |
4186749 |
February 1980 |
Fryer |
4186751 |
February 1980 |
Fleischmann |
4190057 |
February 1980 |
Hill et al. |
4191004 |
March 1980 |
Gmuer et al. |
4191187 |
March 1980 |
Wright et al. |
4192192 |
March 1980 |
Schnell |
4193397 |
March 1980 |
Tucker et al. |
4204547 |
May 1980 |
Allocca |
4206755 |
June 1980 |
Klein et al. |
4206761 |
June 1980 |
Cosman et al. |
4206762 |
June 1980 |
Cosman et al. |
4207903 |
June 1980 |
O'Neill |
4212074 |
July 1980 |
Kuno et al. |
4217221 |
August 1980 |
Masso |
4217588 |
August 1980 |
Freeny, Jr. |
4220189 |
September 1980 |
Marquez |
4221219 |
September 1980 |
Tucker |
4221523 |
September 1980 |
Eberle |
4223837 |
September 1980 |
Gubbiotti |
4226124 |
October 1980 |
Kersten et al. |
4226229 |
October 1980 |
Eckhart et al. |
4227533 |
October 1980 |
Godfrey |
4231376 |
November 1980 |
Lyon et al. |
4232682 |
November 1980 |
Veth |
4237900 |
December 1980 |
Schulman et al. |
4241247 |
December 1980 |
Byrne et al. |
4241870 |
December 1980 |
Marcus |
4245593 |
January 1981 |
Stein |
4246877 |
January 1981 |
Kennedy |
4247850 |
January 1981 |
Marcus |
4248238 |
February 1981 |
Joseph et al. |
4248241 |
February 1981 |
Tacchi |
4256094 |
March 1981 |
Kapp et al. |
4256118 |
March 1981 |
Nagel |
4262343 |
April 1981 |
Claycomb |
4262632 |
April 1981 |
Hanton et al. |
4265241 |
May 1981 |
Portner et al. |
4265252 |
May 1981 |
Chubbuck et al. |
4271018 |
June 1981 |
Drori et al. |
4273070 |
June 1981 |
Hoefelmayr |
4274444 |
June 1981 |
Ruyak |
4275600 |
June 1981 |
Turner et al. |
4275913 |
June 1981 |
Marcus |
4278540 |
July 1981 |
Drori et al. |
4280036 |
July 1981 |
Fukatsu et al. |
4280775 |
July 1981 |
Wood |
4281666 |
August 1981 |
Cosman |
4281667 |
August 1981 |
Cosman |
4284073 |
August 1981 |
Krause et al. |
4285770 |
August 1981 |
Chi et al. |
4291699 |
September 1981 |
Geddes et al. |
4295963 |
October 1981 |
Drori et al. |
4297927 |
November 1981 |
Kuroda et al. |
4303075 |
December 1981 |
Heilman et al. |
4305402 |
December 1981 |
Katims |
4312374 |
January 1982 |
Drori et al. |
4314480 |
February 1982 |
Becker |
4316693 |
February 1982 |
Baxter et al. |
4325387 |
April 1982 |
Helfer |
4327804 |
May 1982 |
Reed |
4328654 |
May 1982 |
Van Ginkel et al. |
4332254 |
June 1982 |
Lundquist |
4332255 |
June 1982 |
Hakim et al. |
4339831 |
July 1982 |
Johnson |
4342218 |
August 1982 |
Fox |
4342308 |
August 1982 |
Trick |
4346604 |
August 1982 |
Snook et al. |
4347851 |
September 1982 |
Jundanian |
4350647 |
September 1982 |
de la Cruz |
4350970 |
September 1982 |
von Tomkewitsch et al. |
4351037 |
September 1982 |
Scherbatskoy |
4351116 |
September 1982 |
Scott, Jr. |
4356486 |
October 1982 |
Mount |
4360010 |
November 1982 |
Finney |
4360277 |
November 1982 |
Daniel et al. |
4361153 |
November 1982 |
Slocum et al. |
4363236 |
December 1982 |
Meyers |
4364276 |
December 1982 |
Schimazoe et al. |
4365425 |
December 1982 |
Gotchel |
4368937 |
January 1983 |
Palombo et al. |
4369013 |
January 1983 |
Abildgaard et al. |
4373527 |
February 1983 |
Fischell |
4376523 |
March 1983 |
Goyen et al. |
4378809 |
April 1983 |
Cosman |
4380427 |
April 1983 |
Hehl et al. |
4385636 |
May 1983 |
Cosman |
4386422 |
May 1983 |
Mumby et al. |
4387715 |
June 1983 |
Hakim et al. |
4387907 |
June 1983 |
Hiestand et al. |
4392368 |
July 1983 |
Folkesson et al. |
4393899 |
July 1983 |
Tsuji et al. |
4393951 |
July 1983 |
Horst-Rudolf et al. |
4395232 |
July 1983 |
Koch |
4395258 |
July 1983 |
Wang et al. |
4395916 |
August 1983 |
Martin |
4398983 |
August 1983 |
Suzuki et al. |
4399705 |
August 1983 |
Weiger et al. |
4399707 |
August 1983 |
Wamstad |
4399809 |
August 1983 |
Baro et al. |
4399821 |
August 1983 |
Bowers |
4403984 |
September 1983 |
Ash et al. |
4404968 |
September 1983 |
Evans, Sr. |
4404974 |
September 1983 |
Titus |
4405318 |
September 1983 |
Whitney et al. |
4407125 |
October 1983 |
Parsons et al. |
4407271 |
October 1983 |
Schiff |
4407296 |
October 1983 |
Anderson |
4407326 |
October 1983 |
Wilhelm |
4408597 |
October 1983 |
Tenney, Jr. |
4415071 |
November 1983 |
Butler et al. |
4416282 |
November 1983 |
Saulson et al. |
4418899 |
December 1983 |
Zimmermann et al. |
4419393 |
December 1983 |
Hanson et al. |
4421124 |
December 1983 |
Marshall |
4421505 |
December 1983 |
Schwartz |
4424720 |
January 1984 |
Bucchianeri |
4428228 |
January 1984 |
Banzhaf et al. |
4428365 |
January 1984 |
Hakky |
4430899 |
February 1984 |
Wessel |
4431009 |
February 1984 |
Marino, Jr. et al. |
4431365 |
February 1984 |
Sturtz, Jr. |
4432363 |
February 1984 |
Kakegawa et al. |
4435173 |
March 1984 |
Siposs et al. |
4439186 |
March 1984 |
Kuhl et al. |
4441491 |
April 1984 |
Evans, Sr. |
4441501 |
April 1984 |
Parent |
4444194 |
April 1984 |
Burcham |
4444498 |
April 1984 |
Heinemann |
4445385 |
May 1984 |
Endo |
4446711 |
May 1984 |
Valente |
4447224 |
May 1984 |
DeCant, Jr. et al. |
4449493 |
May 1984 |
Kopec et al. |
4450811 |
May 1984 |
Ichikawa |
4450946 |
May 1984 |
Olding et al. |
4451033 |
May 1984 |
Nestegard |
4453537 |
June 1984 |
Spitzer |
4453578 |
June 1984 |
Wilder |
4460835 |
July 1984 |
Masuoka et al. |
4464170 |
August 1984 |
Clemens et al. |
4465015 |
August 1984 |
Osta et al. |
4465474 |
August 1984 |
Mardorf et al. |
4466290 |
August 1984 |
Frick |
4468172 |
August 1984 |
Dixon et al. |
4468762 |
August 1984 |
Jurgens et al. |
4469365 |
September 1984 |
Marcus et al. |
4471182 |
September 1984 |
Wielgos et al. |
4471786 |
September 1984 |
Inagaki et al. |
4473067 |
September 1984 |
Schiff |
4473078 |
September 1984 |
Angel |
4476721 |
October 1984 |
Hochreuther et al. |
4478213 |
October 1984 |
Redding |
4478538 |
October 1984 |
Kakino |
4483196 |
November 1984 |
Kurtz et al. |
4484135 |
November 1984 |
Ishihara et al. |
4485813 |
December 1984 |
Anderson et al. |
4489916 |
December 1984 |
Stevens |
4492632 |
January 1985 |
Mattson |
4494411 |
January 1985 |
Koschke et al. |
4494950 |
January 1985 |
Fischell |
4497176 |
February 1985 |
Rubin et al. |
4497201 |
February 1985 |
Allen et al. |
4499394 |
February 1985 |
Koal |
4499691 |
February 1985 |
Karazim et al. |
4499750 |
February 1985 |
Gerber et al. |
4503678 |
March 1985 |
Wimbush |
4511974 |
April 1985 |
Nakane et al. |
4513295 |
April 1985 |
Jones et al. |
4515004 |
May 1985 |
Jaenson |
4515750 |
May 1985 |
Pardini et al. |
4516866 |
May 1985 |
Yamauchi et al. |
4518637 |
May 1985 |
Takeda et al. |
4519401 |
May 1985 |
Ko et al. |
4520443 |
May 1985 |
Yuki et al. |
4522213 |
June 1985 |
Wallroth et al. |
4527568 |
July 1985 |
Rickards et al. |
4529401 |
July 1985 |
Leslie et al. |
4531526 |
July 1985 |
Genest |
4531936 |
July 1985 |
Gordon |
4536000 |
August 1985 |
Rohm et al. |
4537005 |
August 1985 |
Hoyland et al. |
4537129 |
August 1985 |
Heinemann et al. |
4538616 |
September 1985 |
Rogoff |
4540404 |
September 1985 |
Wolvek |
4542461 |
September 1985 |
Eldridge et al. |
4544369 |
October 1985 |
Skakoon et al. |
4545185 |
October 1985 |
Chikatani |
4546524 |
October 1985 |
Kreft |
4548209 |
October 1985 |
Wielders et al. |
4551128 |
November 1985 |
Hakim et al. |
4552150 |
November 1985 |
Zacouto et al. |
4553226 |
November 1985 |
Scherbatskoy |
4556063 |
December 1985 |
Thompson et al. |
4556086 |
December 1985 |
Raines |
4557269 |
December 1985 |
Reynolds et al. |
4557332 |
December 1985 |
Denison et al. |
4559815 |
December 1985 |
Needham et al. |
4560979 |
December 1985 |
Rosskopf et al. |
4561442 |
December 1985 |
Vollmann et al. |
4562751 |
January 1986 |
Nason et al. |
4563175 |
January 1986 |
LaFond |
4565116 |
January 1986 |
Hehl |
4566456 |
January 1986 |
Koning et al. |
4569623 |
February 1986 |
Goldmann |
4570351 |
February 1986 |
Szanto et al. |
4571161 |
February 1986 |
Leblanc et al. |
4571749 |
February 1986 |
Fischell |
4571995 |
February 1986 |
Timme |
4573835 |
March 1986 |
Eckardt et al. |
4574792 |
March 1986 |
Trick |
4576181 |
March 1986 |
Wallace et al. |
4576183 |
March 1986 |
Plicchi et al. |
4577512 |
March 1986 |
Lowenheck et al. |
4581018 |
April 1986 |
Jassawalla et al. |
4581915 |
April 1986 |
Haulsee et al. |
4587840 |
May 1986 |
Dobler et al. |
4589805 |
May 1986 |
Duffner et al. |
4592339 |
June 1986 |
Kuzmak et al. |
4592340 |
June 1986 |
Boyles |
4593703 |
June 1986 |
Cosman |
4595228 |
June 1986 |
Chu |
4595390 |
June 1986 |
Hakim et al. |
4596563 |
June 1986 |
Pande |
4599943 |
July 1986 |
Kobler et al. |
4600855 |
July 1986 |
Strachan et al. |
4602541 |
July 1986 |
Benzinger et al. |
4604089 |
August 1986 |
Santangelo et al. |
4605354 |
August 1986 |
Daly |
4606419 |
August 1986 |
Perini |
4606478 |
August 1986 |
Hack et al. |
4610256 |
September 1986 |
Wallace |
4614137 |
September 1986 |
Jones |
4615691 |
October 1986 |
Hakim et al. |
4617016 |
October 1986 |
Blomberg et al. |
4618861 |
October 1986 |
Gettens et al. |
4620807 |
November 1986 |
Polit |
4621331 |
November 1986 |
Iwata |
4622871 |
November 1986 |
Van Sickle et al. |
4626462 |
December 1986 |
Kober et al. |
4633304 |
December 1986 |
Nagasaki et al. |
4633878 |
January 1987 |
Bombardieri et al. |
4635182 |
January 1987 |
Hintz |
4637736 |
January 1987 |
Andeen et al. |
4638665 |
January 1987 |
Benson et al. |
4644246 |
February 1987 |
Knapen et al. |
4646553 |
March 1987 |
Tufte et al. |
4648363 |
March 1987 |
Kronich |
4648406 |
March 1987 |
Miller |
4658358 |
April 1987 |
Leach et al. |
4658760 |
April 1987 |
Zehuhr |
4660568 |
April 1987 |
Cosman |
4665511 |
May 1987 |
Rodney et al. |
4665896 |
May 1987 |
LaForge et al. |
4669484 |
June 1987 |
Masters |
4672974 |
June 1987 |
Lee |
4674457 |
June 1987 |
Berger et al. |
4674546 |
June 1987 |
Fournier et al. |
4678408 |
July 1987 |
Nason et al. |
4681559 |
July 1987 |
Hooven |
4683850 |
August 1987 |
Bauder et al. |
4685463 |
August 1987 |
Williams |
4685469 |
August 1987 |
Keller et al. |
4685903 |
August 1987 |
Cable et al. |
4686979 |
August 1987 |
Gruen et al. |
4686987 |
August 1987 |
Salo et al. |
4687530 |
August 1987 |
Berscheid et al. |
4691694 |
September 1987 |
Boyd et al. |
4691710 |
September 1987 |
Dickens et al. |
4693253 |
September 1987 |
Adams |
4695237 |
September 1987 |
Inaba et al. |
4696189 |
September 1987 |
Hochreuther et al. |
4697574 |
October 1987 |
Karcher et al. |
4698038 |
October 1987 |
Key et al. |
4700497 |
October 1987 |
Sato et al. |
4700610 |
October 1987 |
Bauer et al. |
4701143 |
October 1987 |
Key et al. |
4703756 |
November 1987 |
Gough et al. |
4705507 |
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May 1988 |
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June 1988 |
Mack |
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July 1988 |
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Merrick |
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Wadham et al. |
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September 1988 |
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September 1988 |
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October 1988 |
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Peel et al. |
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November 1988 |
Demer |
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November 1988 |
Fogarty |
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November 1988 |
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November 1988 |
Wallace |
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December 1988 |
Sterghos |
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December 1988 |
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January 1989 |
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January 1989 |
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February 1989 |
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February 1989 |
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April 1989 |
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April 1989 |
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April 1989 |
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July 1989 |
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July 1989 |
Berci |
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July 1989 |
Brockway et al. |
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July 1989 |
Hehl et al. |
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August 1989 |
Pollack |
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September 1989 |
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September 1989 |
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September 1989 |
Schaldach |
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September 1989 |
Delphia et al. |
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September 1989 |
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September 1989 |
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October 1989 |
Feingold et al. |
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October 1989 |
Shah |
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October 1989 |
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October 1989 |
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October 1989 |
Vollmann et al. |
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November 1989 |
Baker, Jr. et al. |
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November 1989 |
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December 1989 |
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January 1990 |
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January 1990 |
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January 1990 |
Baur et al. |
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February 1990 |
Daly et al. |
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February 1990 |
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February 1990 |
Cohen |
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February 1990 |
Cohen |
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February 1990 |
Mathies et al. |
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February 1990 |
Moore et al. |
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March 1990 |
Strohl et al. |
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March 1990 |
Kakimoto et al. |
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April 1990 |
Fahlstrom et al. |
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April 1990 |
Ayers |
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May 1990 |
Frank |
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May 1990 |
Kawai et al. |
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June 1990 |
Berkovits |
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June 1990 |
Maxwell |
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June 1990 |
Kresh et al. |
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July 1990 |
Eckert et al. |
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July 1990 |
Alexander, III et al. |
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July 1990 |
Catanzaro |
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July 1990 |
Shames et al. |
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July 1990 |
Sholder |
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July 1990 |
Hon et al. |
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August 1990 |
Lessi et al. |
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August 1990 |
Mahutte et al. |
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August 1990 |
Mauerer et al. |
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August 1990 |
Carroll et al. |
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September 1990 |
Kaiser et al. |
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September 1990 |
Alberter et al. |
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September 1990 |
Rosenbluth et al. |
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September 1990 |
Cadell et al. |
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October 1990 |
Grooters |
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October 1990 |
Evans et al. |
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November 1990 |
Grimaldo |
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November 1990 |
Nathanielsz |
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November 1990 |
Chen et al. |
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November 1990 |
Dobrick et al. |
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December 1990 |
Robinson et al. |
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December 1990 |
Arthur, III |
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December 1990 |
Melsky et al. |
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December 1990 |
Holbrook et al. |
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December 1990 |
McCurdy |
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January 1991 |
Segalowitz |
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January 1991 |
Perkins et al. |
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January 1991 |
Aoki et al. |
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January 1991 |
Funke et al. |
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January 1991 |
Ito |
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February 1991 |
Brouwers |
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March 1991 |
Yano et al. |
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March 1991 |
Bahraman |
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April 1991 |
Terrell et al. |
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April 1991 |
Hafelfinger et al. |
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April 1991 |
Alt |
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April 1991 |
Wallace |
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April 1991 |
Schnut |
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April 1991 |
Fearnot et al. |
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April 1991 |
Lahr |
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April 1991 |
Ohta et al. |
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April 1991 |
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April 1991 |
Grohn et al. |
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April 1991 |
Dardik |
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April 1991 |
Silva et al. |
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April 1991 |
Wallace et al. |
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April 1991 |
Sholder |
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April 1991 |
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May 1991 |
Strand et al. |
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May 1991 |
Lemay et al. |
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May 1991 |
Weaver et al. |
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May 1991 |
Robertson |
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May 1991 |
Robinson et al. |
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June 1991 |
Falcoff et al. |
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June 1991 |
Wallace |
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June 1991 |
Russie |
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June 1991 |
Chang et al. |
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June 1991 |
Tajima et al. |
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June 1991 |
Johnsen et al. |
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July 1991 |
Giles et al. |
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July 1991 |
Sweet |
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August 1991 |
Inahara et al. |
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August 1991 |
Oba |
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August 1991 |
Koenig et al. |
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August 1991 |
Milheiser |
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August 1991 |
Torok et al. |
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September 1991 |
Haghkar |
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September 1991 |
Kimura et al. |
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September 1991 |
Arai et al. |
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September 1991 |
Falcoff |
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October 1991 |
Hehl et al. |
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October 1991 |
Bajaj |
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October 1991 |
Foote et al. |
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October 1991 |
Geddes et al. |
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October 1991 |
Shiels |
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October 1991 |
Sparer et al. |
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October 1991 |
Shirai et al. |
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November 1991 |
Vigneau et al. |
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November 1991 |
Grandjean et al. |
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November 1991 |
Sullivan et al. |
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December 1991 |
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December 1991 |
Chong |
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January 1992 |
Melbye et al. |
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January 1992 |
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January 1992 |
Jonasson et al. |
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January 1992 |
Collins et al. |
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January 1992 |
DeMichele |
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February 1992 |
Galen et al. |
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February 1992 |
Fink, Jr. et al. |
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February 1992 |
Strzodka |
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February 1992 |
McEachern et al. |
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March 1992 |
Troyk et al. |
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March 1992 |
Portman |
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March 1992 |
Lekholm |
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March 1992 |
Abrams |
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March 1992 |
Besz et al. |
5103832 |
April 1992 |
Jackson |
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April 1992 |
Collins et al. |
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April 1992 |
Olive |
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May 1992 |
Petros et al. |
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May 1992 |
Funke et al. |
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May 1992 |
Nappholz et al. |
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May 1992 |
Lee |
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June 1992 |
Grevious |
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June 1992 |
Elftman |
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June 1992 |
Leininger et al. |
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July 1992 |
Fink, Jr. et al. |
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July 1992 |
Mehra |
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July 1992 |
Hehl et al. |
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July 1992 |
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July 1992 |
Pless et al. |
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July 1992 |
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August 1992 |
Foote et al. |
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August 1992 |
Hazon et al. |
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September 1992 |
Olson |
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September 1992 |
Dyckow et al. |
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September 1992 |
Ellis |
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October 1992 |
Bangmark et al. |
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October 1992 |
Pinchuk |
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October 1992 |
Bennett et al. |
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October 1992 |
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October 1992 |
East et al. |
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October 1992 |
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October 1992 |
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November 1992 |
Cohen |
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November 1992 |
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December 1992 |
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December 1992 |
Rabenau et al. |
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December 1992 |
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December 1992 |
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December 1992 |
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December 1992 |
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December 1992 |
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January 1993 |
Sanderson et al. |
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January 1993 |
Healy |
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January 1993 |
Philipps et al. |
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January 1993 |
Hickey |
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February 1993 |
Baird |
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February 1993 |
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February 1993 |
Austin |
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February 1993 |
Farb et al. |
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February 1993 |
Schirmacher et al. |
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February 1993 |
Nappholz et al. |
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February 1993 |
Orth |
5192314 |
March 1993 |
Daskalakis |
5195362 |
March 1993 |
Eason |
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March 1993 |
Indravudh |
5199427 |
April 1993 |
Strickland |
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April 1993 |
Obel et al. |
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April 1993 |
Lampropoulos et al. |
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April 1993 |
Stinton |
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May 1993 |
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May 1993 |
McGorry et al. |
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May 1993 |
Lampropoulos et al. |
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May 1993 |
Taylor et al. |
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May 1993 |
Stef et al. |
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May 1993 |
Maloney |
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May 1993 |
Avanzini |
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June 1993 |
Williams et al. |
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June 1993 |
Stobbe et al. |
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June 1993 |
Strickland |
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July 1993 |
Kuzmak |
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July 1993 |
Seiffert et al. |
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July 1993 |
Rosenblum |
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August 1993 |
Hudrlik |
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August 1993 |
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September 1993 |
Harriehausen et al. |
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September 1993 |
Derlien et al. |
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September 1993 |
Mueller et al. |
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October 1993 |
Nusser |
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October 1993 |
Bley |
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October 1993 |
Rondelet et al. |
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October 1993 |
Samiotes et al. |
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November 1993 |
Centa et al. |
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November 1993 |
Polyak et al. |
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December 1993 |
Moulder |
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December 1993 |
Saperston |
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December 1993 |
Colin et al. |
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December 1993 |
Wahlstrand et al. |
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January 1994 |
Redman et al. |
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January 1994 |
Potts |
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February 1994 |
Roline et al. |
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February 1994 |
Hudrlik |
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March 1994 |
Nagy et al. |
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March 1994 |
Merin et al. |
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March 1994 |
Rondelet et al. |
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March 1994 |
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March 1994 |
Gilmore et al. |
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April 1994 |
Koestner |
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April 1994 |
Knapp et al. |
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April 1994 |
Mrklas et al. |
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April 1994 |
Kirschner et al. |
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May 1994 |
Adams et al. |
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May 1994 |
Salo |
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May 1994 |
Shelton et al. |
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May 1994 |
Yomtov et al. |
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May 1994 |
Mulier |
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May 1994 |
Jeutter et al. |
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June 1994 |
Grevious |
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July 1994 |
Ballheimer et al. |
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July 1994 |
Weissfloch et al. |
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July 1994 |
Lord et al. |
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July 1994 |
Boute et al. |
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August 1994 |
Wallock |
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August 1994 |
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August 1994 |
Spano et al. |
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August 1994 |
Thompson |
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September 1994 |
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September 1994 |
McBean, Sr. |
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September 1994 |
Linzell et al. |
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September 1994 |
Young et al. |
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September 1994 |
Miller et al. |
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October 1994 |
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October 1994 |
Theener |
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October 1994 |
Pohndorf et al. |
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October 1994 |
Klein et al. |
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October 1994 |
Keimel |
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October 1994 |
Wyborny et al. |
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November 1994 |
Leonard et al. |
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November 1994 |
McBean, Sr. |
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November 1994 |
Solomon |
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November 1994 |
Todd et al. |
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November 1994 |
Carney |
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December 1994 |
Hudrlik |
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December 1994 |
Harrison et al. |
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December 1994 |
McBean |
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December 1994 |
McBean |
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January 1995 |
Johnson et al. |
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January 1995 |
Hague et al. |
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January 1995 |
Adams |
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February 1995 |
Yomtov et al. |
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February 1995 |
Lee et al. |
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February 1995 |
Quadri et al. |
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March 1995 |
Mitchell et al. |
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March 1995 |
Strittmatter |
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April 1995 |
Pape et al. |
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April 1995 |
Tansey |
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April 1995 |
Olson |
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May 1995 |
Yomtov |
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May 1995 |
Winston et al. |
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May 1995 |
Andersen et al. |
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May 1995 |
Ljungstroem et al. |
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May 1995 |
Juma |
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May 1995 |
Salo et al. |
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June 1995 |
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June 1995 |
Taylor et al. |
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July 1995 |
Harrison et al. |
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July 1995 |
Lampropoulos et al. |
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July 1995 |
Snaper et al. |
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July 1995 |
Lim et al. |
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August 1995 |
Helmy et al. |
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August 1995 |
Fackler |
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September 1995 |
Peterson |
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September 1995 |
Taylor et al. |
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September 1995 |
Kuzmak |
5456690 |
October 1995 |
Duong-Van |
5461293 |
October 1995 |
Rozman et al. |
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October 1995 |
Hoshen |
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November 1995 |
Neumann |
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November 1995 |
Smith et al. |
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December 1995 |
Joseph |
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January 1996 |
Walter et al. |
5482049 |
January 1996 |
Addiss et al. |
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January 1996 |
Villafana |
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February 1996 |
Rosenberg |
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February 1996 |
Sanderson et al. |
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February 1996 |
Uber, III et al. |
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February 1996 |
Kirschner et al. |
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April 1996 |
Libman et al. |
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April 1996 |
Berry, Jr. |
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April 1996 |
Ebert et al. |
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April 1996 |
Palmskog et al. |
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April 1996 |
Deno |
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April 1996 |
Miller |
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April 1996 |
DeRidder |
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May 1996 |
Hartmann et al. |
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May 1996 |
Srisathapat et al. |
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May 1996 |
Polyak |
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May 1996 |
Schoolman et al. |
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June 1996 |
Burgmann et al. |
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July 1996 |
Wahlstrand et al. |
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July 1996 |
Halperin et al. |
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July 1996 |
Harrison et al. |
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July 1996 |
Testerman |
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July 1996 |
Walter et al. |
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August 1996 |
Conero et al. |
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August 1996 |
O'Connor et al. |
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August 1996 |
Olson et al. |
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August 1996 |
Stevens |
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August 1996 |
Johnson et al. |
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September 1996 |
Altman |
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September 1996 |
Hickey |
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September 1996 |
Block et al. |
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September 1996 |
Boyd et al. |
5564434 |
October 1996 |
Halperin et al. |
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November 1996 |
Melsky et al. |
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December 1996 |
Stevens et al. |
5586629 |
December 1996 |
Shoberg et al. |
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January 1997 |
Brown |
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January 1997 |
Martinelli |
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January 1997 |
Renger |
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January 1997 |
Walter et al. |
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January 1997 |
Goldfarb |
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January 1997 |
Weltlich et al. |
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March 1997 |
Chan et al. |
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March 1997 |
Tutrone, Jr. |
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March 1997 |
Walter et al. |
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April 1997 |
Schoonen et al. |
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April 1997 |
Sloane |
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April 1997 |
Lewis et al. |
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May 1997 |
Wildeson et al. |
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May 1997 |
Kieval et al. |
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May 1997 |
Markowitz et al. |
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May 1997 |
Prem et al. |
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June 1997 |
Bishop et al. |
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June 1997 |
Bertrand et al. |
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July 1997 |
Rise |
5645065 |
July 1997 |
Shapiro et al. |
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July 1997 |
McDonald |
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July 1997 |
Burgmann et al. |
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October 1997 |
Bishop et al. |
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October 1997 |
Noren et al. |
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October 1997 |
Ford et al. |
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November 1997 |
Vandervalk et al. |
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November 1997 |
Dempsey et al. |
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December 1997 |
Kaemmerer |
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December 1997 |
Stevens et al. |
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December 1997 |
Ecker et al. |
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December 1997 |
Wang et al. |
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January 1998 |
Tremblay et al. |
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January 1998 |
Lampropoulos et al. |
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February 1998 |
Seiberth et al. |
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February 1998 |
Chen |
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February 1998 |
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|
Primary Examiner: Lacyk; John P
Attorney, Agent or Firm: Frost Brown Todd LLC
Parent Case Text
PRIORITY
This application is a continuation-in-part of prior co-pending U.S.
Non-Provisional application Ser. No. 11/369,682, filed Mar. 7,
2006, entitled "System and Method for Determining Implanted Device
Positioning and Obtaining Pressure Data," and published as U.S.
Pub. No. 2006/0211914; which is a continuation-in-part of prior
co-pending U.S. Non-Provisional application Ser. No. 11/065,410,
filed Feb. 24, 2005, entitled "Device for Non-Invasive Measurement
of Fluid Pressure in an Adjustable Restriction Device," published
as U.S. Pub. No. 2006/0189888. The disclosure of each of those
applications and publications is incorporated by reference herein.
Claims
What is claimed is:
1. A system for detecting the orientation of an implant component,
the system comprising: (a) an implantable component, wherein the
implantable component comprises a first coil operable to
transcutaneously transmit a first signal comprising a pattern of
pulses, wherein either at least two adjacent pulses in the pattern
have a different duration or pulses within the pattern are provided
at a different frequency relative to the frequency of other pulses
within the pattern, wherein the implantable component is configured
to be implanted within a patient; (b) an external component,
wherein the external component comprises a second coil operable to
detect the pattern of pulses transcutaneously transmitted by the
first coil; and (c) a logic component in communication with the
second coil, wherein the logic component is configured to process
the pattern of pulses emitted by the first coil as detected by the
second coil and determine the orientation of the first coil
relative to the second coil based on the pattern of pulses emitted
by the first coil as detected by the second coil.
2. The system of claim 1, further comprising an implantable gastric
band system, wherein the implantable component is part of the
implantable gastric band system.
3. The system of claim 2, wherein the gastric band system comprises
an injection port.
4. The system of claim 3, wherein the implantable component
comprises the injection port.
5. The system of claim 4, wherein the first coil is located within
the injection port.
6. The system of claim 2, further comprising a pressure sensor,
wherein the pressure sensor is configured to sense fluid pressure
within the gastric band system.
7. The system of claim 6, wherein the first coil is in
communication with the pressure sensor, wherein the first coil is
operable to transmit pressure information obtained by the pressure
sensor.
8. The system of claim 6, wherein the gastric band system comprises
an injection port, wherein the pressure sensor is located within
the injection port.
9. The system of claim 1, wherein the external component comprises
a sense head operable to detect the position of the implantable
component when the implantable component is located within the
patient.
10. The system of claim 9, wherein the sense head comprises a
plurality of coils, wherein the plurality of coils are operable to
detect the position of the implantable component when the
implantable component is located within the patient.
11. The system of claim 1, wherein the first signal has a first
amplitude, wherein the second coil is further operable to transmit
a second signal having a second amplitude, wherein the logic
component is further operable to detect the orientation of the
first coil relative to the second coil by comparing the first
amplitude with the second amplitude.
12. The system of claim 1, wherein the external component comprises
a plurality of additional coils.
13. The system of claim 11, wherein the external component
comprises a plurality of additional coils, wherein the plurality of
additional coils are operable to transmit the second signal.
14. A system for detecting the orientation of an implant component,
the system comprising: (a) an implantable component, wherein the
implantable component is configured to be implanted within a
patient; (b) an external component, wherein the external component
is operable to communicate with at least a portion of the
implantable component; and (c) a orientation detection component,
wherein the orientation detection component is operable to
determine an orientation of the implantable component relative to
the external component, wherein the orientation detection component
comprises an accelerometer or a tilt sensor, wherein the
accelerometer or tilt sensor is positioned on or in the implantable
component, wherein the accelerometer or tilt sensor comprises a
member configured to move relative to the implantable component in
accordance with the orientation of the implantable component.
15. The system of claim 14, wherein the implantable component
comprises a first coil, wherein the external component comprises a
second coil configured to communicate with the first coil.
16. The system of claim 1, wherein the first coil is operable to
transmit a first signal having a phase, wherein the second coil is
operable to transmit a second signal having a phase, and wherein
the orientation detection component comprises a logic component
operable to compare the phase of the first signal with the phase of
the second signal, wherein the logic component is further
configured to determine an orientation of the first coil relative
to the second coil based on a comparison of the phase of the first
signal with the phase of the second signal.
17. A method of detecting the orientation of an implanted
component, the method comprising: (a) providing an external coil
external to a patient, wherein the patient has an implanted
component operable to transmit a first signal having a phase,
wherein the implanted component has a center, wherein the external
coil is operable to transmit a second signal having a phase; (b)
positioning the external coil at a location approximately over the
center of the implanted component; (c) receiving the first signal
transmitted by the implanted component; (d) comparing the phase of
the first signal with the phase of the second signal; (e)
determining the orientation of the implanted component relative to
the external coil, based on the comparison of the phase of the
first signal and the phase of the second signal; and (f) moving the
external coil within a region surrounding the location
approximately over the center of the implanted component, wherein
the act of determining the orientation of the implanted component
relative to the external coil further comprises monitoring changes
between the phase of the first signal and the phase of the second
signal as the external coil is moved within the region.
Description
BACKGROUND
Many devices and methods for treating obesity have been made and
used, including but not limited to adjustable gastric bands. An
example of such an adjustable gastric band is disclosed in U.S.
Pat. No. 6,067,991, entitled "Mechanical Food Intake Restriction
Device" which issued on May 30, 2000, and which is incorporated
herein by reference. Some fluid-based adjustable gastric band
systems include an implanted port for the injection and withdrawal
of fluid from the gastric band system. Insertion of a needle, or
otherwise engaging a port, may be difficult in some situations
where the port is oriented within a patient in certain ways (e.g.,
when a port is flipped upside-down). The foregoing examples are
merely illustrative and not exhaustive. While a variety of
techniques and devices have been used treat obesity, it is believed
that no one prior to the inventors has previously made or used an
invention as described in the appended claims.
BRIEF DESCRIPTION OF THE FIGURES
While the specification concludes with claims which particularly
point out and distinctly claim the invention, it is believed the
present invention will be better understood from the following
description of certain examples taken in conjunction with the
accompanying drawings, in which like reference numerals identify
the same elements and in which:
FIG. 1 is a schematic illustration of an exemplary food intake
restriction device;
FIG. 2 is a more detailed perspective view of an exemplary
implantable portion for the food intake restriction device of FIG.
1;
FIG. 3 is a perspective view of the adjustable gastric band of FIG.
2, showing the band positioned around the gastro-esophageal
junction of a patient;
FIG. 4 is a cross-sectional view of the adjustable gastric band of
FIG. 2, shown in a deflated configuration;
FIG. 5 is a cross-sectional view of the adjustable gastric band of
FIG. 2, shown in an inflated configuration to create a food intake
restriction;
FIG. 6 is a block diagram representing an exemplary pressure
measurement system;
FIG. 7 is a side, partially cross-sectioned view of the injection
port shown in FIG. 2;
FIG. 8 is an isometric view of the retaining cover shown in FIG.
7;
FIG. 9 is a side cross-sectional view illustrating an exemplary
pressure sensing system incorporated into the injection port shown
in FIG. 2;
FIG. 10 is a perspective view of an exemplary sense head;
FIG. 11 a plan view of the sense head of FIG. 10;
FIG. 12 is a side, cross-sectional view of the sense head of FIG.
11, taken along line 12-12;
FIG. 13 is a side, cross-sectional view of the sense head of FIG.
11, taken along line 13-13;
FIG. 14 is a graph showing a pair of curves representing signals
that are out of phase;
FIG. 15 is a graph showing a pair of curves representing signals
that are in phase;
FIG. 16 illustrates two patterned pulsed signals compared to a
reference pulsed signal;
FIG. 17 is a perspective view of an exemplary accelerometer;
FIG. 18 is a side, cross-sectional view of the accelerometer of
FIG. 17, under an acceleration in at least one lateral
direction;
FIG. 19 is a side, cross-sectional view of the accelerometer of
FIG. 17, under an acceleration in a vertical direction;
FIG. 20 is a plan view of an exemplary tilt sensor;
FIG. 21 is a plan view of an alternative exemplary sense head;
FIG. 22 is a perspective view of an exemplary display device
suitable for coupling with the sense head of FIG. 10;
FIG. 23 is an exemplary graphical display suitable for the display
device of FIG. 22;
FIG. 24 is the graphical display of FIG. 23 indicating suitable
positioning of the sense head of FIG. 10; and
FIG. 25 is a graph indicating a pressure signal from a pressure
sensing system, such as may appear on an external monitor display
during interrogation by a user.
DETAILED DESCRIPTION
The following description of certain examples of the invention
should not be used to limit the scope of the present invention.
Other examples, features, aspects, embodiments, and advantages of
the invention will become apparent to those skilled in the art from
the following description, which is by way of illustration, one of
the best modes contemplated for carrying out the invention. As will
be realized, the invention is capable of other different and
obvious aspects, all without departing from the invention.
Accordingly, the drawings and descriptions should be regarded as
illustrative in nature and not restrictive.
Referring now to the drawings in detail, wherein like numerals
indicate the same elements throughout the views, FIG. 1 illustrates
a food intake restriction system 30. System 30 comprises a first
portion, identified generally as 32, implanted inside of a patient
34, and a second portion, identified generally as 36, located
external to the patient. Implanted portion 32 comprises an
adjustable gastric band 38 positioned on the upper portion of the
patient's stomach 40. Adjustable band 38 may include a cavity made
of silicone rubber, or another type of biocompatible material, that
inflates inwardly against stomach 40 when filled with a fluid.
Alternatively, band 38 may comprise a mechanically adjustable
device having a fluid cavity that experiences pressure changes with
band adjustments, or a combination hydraulic/mechanical adjustable
band. An injection port 42, which will be described in greater
detail below, is implanted in a body region accessible for needle
injections and/or telemetry communication signals. In the
embodiment shown, injection port 42 fluidly communicates with
adjustable band 38 via a catheter 44. A surgeon may position and
permanently implant injection port 42 inside the body of the
patient in order to perform adjustments of the food intake
restriction or stoma. Those skilled in the art will recognize that
the surgical methods for placing gastric band systems such as
implantable portion 32 have evolved greatly during recent years so
that the patient may derive optimal therapeutic effect with minimal
complications. The surgeon, for example, typically implants
injection port 42 in the lateral, subcostal region of the patient's
abdomen under the skin and layers of fatty tissue. The surgeon may
also implant injection port 42 on the sternum of the patient.
FIG. 2 illustrates an exemplary adjustable gastric band in greater
detail. In this embodiment, band 38 includes a variable volume
cavity 46 that expands or contracts against the outer wall of the
stomach to form an adjustable stoma for controllably restricting
food intake into the stomach. A physician may decrease the size of
the stoma opening by adding fluid to variable volume cavity 46 or,
alternatively, may increase the stoma size by withdrawing fluid
from the cavity. Fluid may be added or withdrawn by inserting a
needle into injection port 42. Alternatively, fluid may be
transferred in a non-invasive manner between band 38 and injection
port 42 using telemetry command signals. The fluid may be, but is
not restricted to, a 0.9 percent saline solution.
FIG. 3 shows the adjustable gastric band 38 of FIG. 2 applied about
the gastro-esophageal junction of a patient. As shown in FIG. 3,
band 38 at least substantially encloses the upper portion of
stomach 40 near the junction with esophagus 48. FIG. 4 is a
sectional view of band 38, showing the band in a deflated
configuration. In this view, band 38 contains little to no fluid,
thereby maximizing the size of the stoma opening into stomach 40.
FIG. 5 is a cross-sectional view of band 38 and stomach 40, similar
to FIG. 4, showing band 38 in an inflated, fluid-filled
configuration. In this view, the pressure of band 38 against
stomach 40 is increased due to the fluid within the band, thereby
decreasing the stoma opening to create a food intake restriction.
FIG. 5 also schematically illustrates the dilation of esophagus 48
above band 38 to form an upper pouch 50 beneath the diaphragm
muscle 52 of the patient.
Returning now to FIG. 1, external portion 36 of food restriction
system 30 comprises a pressure-reading device 60 electrically
connected (in this embodiment via an electrical cable assembly 62)
to a control box 64. Control box 64 includes a display 66, one or
more control switches 68, and an external control module, which
will be explained in further detail below. Control box 64 may be
configured for use, for example, in a physician's office or
examination room. Some ways to mount control box 64 include
placement upon a desktop, attachment to an examination table, or
hanging on a portable stand. Control box 64 may also be configured
for carrying in the physician's lab coat pocket, holding by hand,
or placing upon the examination table or the reclining patient.
Electrical cable assembly 62 may be detachably connected to control
box 64 or pressure-reading device 60 to facilitate cleaning,
maintenance, usage, and storage of external portion 36 of system
30. Pressure-reading device 60 non-invasively measures the pressure
of the fluid within implanted portion 32 even when injection port
42 is implanted beneath thick (at least over 10 centimeters)
subcutaneous fat tissue. The physician may hold pressure-reading
device 60 against the patient's skin near the location of injection
port 42 in the patient and observe the pressure reading on display
66 of control box 64. Pressure-reading device 60 may also be
removably attached to the patient, such as during a prolonged
examination, using straps, adhesives, and other well-known methods.
Pressure-reading device 60 operates through conventional cloth or
paper surgical drapes, and may also include a disposal cover (not
shown) that may be replaced for each patient.
FIG. 6 is a block diagram of an exemplary pressure measurement
system consistent with embodiments described in greater detail
below. As shown in FIG. 6, an external control module 126 of the
system includes a primary TET coil 130 for transmitting a power
signal to the internal control module, indicated generally as 132.
Primary TET coil 130 is located in pressure reading device 60 shown
in FIG. 1. A TET drive circuit 134 controls the application of a
power signal to primary TET coil 130. TET drive circuit 134 is
controlled by a microprocessor 136 having an associated memory 138.
A graphical user interface 140 is connected to microprocessor 136
for controlling the data shown on display 66. External control
module 126 also includes a primary telemetry transceiver 142 for
transmitting interrogation commands to and receiving response data,
including fluid pressure readings, from implant control module 132
via telemetry coil 144.
While TET coil 130 and telemetry coil 144 are shown as separate
coils, it will be appreciated that functions of TET and telemetry
may alternatively be provided by the same coil or by one or more
other structures. In this example, primary transceiver 142 is
electrically connected to microprocessor 136 for inputting and
receiving command and data signals. Primary transceiver 142
resonates at a selected RF communication frequency to generate a
downlink alternating magnetic field 146 that transmits command data
to implant control module 132. A power supply 150 supplies energy
to external control module 126 in order to power system 30. An
ambient pressure sensor 152 is connected to microprocessor 136.
Microprocessor 136 uses the signal from ambient pressure sensor 152
to adjust the pressure reading for variations in atmospheric
pressure due to, for example, variations in barometric conditions
or altitude, in order to increase the accuracy of the pressure
measurement. Of course, all of these components are merely
exemplary, and any of these components may be omitted, substituted,
supplemented, or rearranged as desired.
FIG. 6 also illustrates internal control module 132 implanted
beneath the patient's skin 154. Internal control module 132 is
located within injection port 42 in this example. As shown in FIG.
12, a secondary TET/telemetry coil 156 in internal control module
132 receives power and communication signals from external control
module 126. Coil 156 forms a tuned tank circuit that is inductively
coupled with either primary TET coil 130 to power the implant, or
primary telemetry coil 144 to receive and transmit data. A
telemetry transceiver 158 controls data exchange with coil 156.
Additionally, internal control module 132 includes a
rectifier/power regulator 160, microcontroller 106 described above,
a memory 162 associated with the microcontroller, temperature
sensor 112, pressure sensor 84 and a signal conditioning circuit
164 for amplifying the signal from the pressure sensor. Internal
control module 132 transmits the temperature adjusted pressure
measurement from pressure sensor 84 to external control module 126.
In external module 126, the received pressure measurement signal is
adjusted for changes in ambient pressure and shown on display 66.
Again, though, these components are merely exemplary, and any of
these components may be omitted, substituted, supplemented, or
rearranged as desired.
Turning now to FIG. 7, which depicts a side, partially sectioned
view of injection port 42 containing a pressure sensing system for
non-invasively measuring the fluid pressure within implanted
portion 32. As shown in FIG. 7, injection port 42 comprises a rigid
housing 70 having an annular flange 72 containing a plurality of
attachment holes 74 for fastening the injection port to tissue in a
patient. A surgeon may attach injection port 42 to the tissue, such
as the fascia covering an abdominal muscle, using any one of
numerous surgical fasteners including suture filaments, staples,
and clips. Injection port 42 further comprises a septum 76
typically made of a silicone rubber and compressively retained in
housing 70. Septum 76 is penetrable by a Huber needle, or a similar
type of injection instrument, for adding or withdrawing fluid from
the port. Septum 76 self-seals upon withdrawal of the syringe
needle to maintain the volume of fluid inside of injection port
42.
Injection port 42 of the present example further comprises a
reservoir 80 for retaining a working fluid and a catheter connector
82. Connector 82 attaches to catheter 44, shown in FIG. 2, to form
a closed hydraulic circuit between reservoir 80 inside of injection
port 42 and cavity 46 within adjustable band 38. Fluid from
reservoir 80 may be used to expand the volume of band cavity 46.
Alternatively, fluid may be removed from cavity 46 and retained in
reservoir 80 in order to temporarily decrease the volume of cavity
46. Housing 70 and connector 82 may be integrally molded from a
biocompatible polymer, constructed from a metal such as titanium or
stainless steel, or be made from any other suitable
material(s).
In one embodiment, described in greater detail below, a pressure
sensing system is provided in injection port 42 to measure the
fluid pressure within the closed hydraulic circuit of implanted
portion 32. The pressure within the circuit may correspond to the
amount of restriction applied by adjustable band 38 to the
patient's stomach. Accordingly, measuring the fluid pressure may
enable a physician to evaluate the restriction created by a band
adjustment. Fluid pressure may be measured before, during, and/or
after an adjustment to verify that the band is properly adjusted.
In the embodiment shown in FIG. 7, the pressure sensing system
comprises a sensor system 1088 positioned at the bottom of fluid
reservoir 80 within housing 70. A retaining cover 86 extends above
sensor system 1088 to substantially separate the sensor system 1088
from reservoir 80, and to protect components of the sensor system
1088 from needle penetration. Retaining cover 86 may be made of a
ceramic material such as, for example, alumina, which resists
needle penetration yet does not interfere with electronic
communications between sensor system 1088 and pressure-reading
device 60. Retaining cover 86 includes a vent 90 that allows fluid
inside of reservoir 80 to flow to and impact upon the surface of
sensor system 1088.
FIG. 8 is an isometric view of retaining cover 86 illustrating vent
90 in the bottom surface of the cover. Housing 94 is sealed to port
housing 70 to prevent the loss of fluid from the injection port 42.
As fluid flows through vent 90 in reservoir 80, the fluid impacts
upon the surface of sensor system 1088. The fluid flow through vent
90 enables sensor system 1088 to respond to fluid pressure changes
within the hydraulic circuit and convert the pressure changes into
a usable form of data.
An exemplary sensor system 1088 suitable for incorporation into
port 42 is shown in FIG. 9. In this example, pressure sensing
system 1088 comprises an upper member 1092 and a housing 94.
Pressure sensing system 1088 may be positioned beneath retaining
cover 86 of port 42. Alternatively, upper member 1092 may be
integral with retaining cover 86, such that upper member 1092
provides a bottom for retaining cover 86 or reservoir 80. Other
suitable configurations will be apparent to those of ordinary skill
in the art. In the present example, upper member 1092 is in fluid
communication with fluid located within port 42, such that the
pressure of such fluid is exerted against upper member 1092.
Pressure sensing system 1088 further comprises a microcontroller
106, a TET/telemetry coil 114, and a capacitor 116. Optionally,
pressure sensing system 1088 may further comprise a temperature
sensor (not shown). Microcontroller 106, TET/telemetry coil 114,
and capacitor 116 may be in communication via a circuit board (not
shown) or any via any other suitable component(s). It will also be
appreciated that TET/telemetry coil 114 and capacitor 116 may
collectively form a tuned tank circuit for receiving power from
external portion 36, and transmitting the pressure measurement to
pressure reading device 60.
In the embodiment of pressure sensing system 1088 depicted in FIG.
9, a fluid access port 1094 is provided in upper member 1092, and
is in fluid communication with a pressure sensor 1120. A hermetic
seal 1122 secures pressure sensor 1120 to the bottom of upper
member 1092. Pressure sensor 1120 is configured to sense pressure
of fluid adjacent to upper member 1092, which is communicated to
pressure sensor 1120 via fluid access port 1094. Pressure sensor
1120 is further in communication with microcontroller 106, such
that pressure measurements obtained using pressure sensor 1120 may
be communicated to or through microcontroller 106 and thus via coil
114 to an external telemetry device (e.g., pressure reading device
60).
In one embodiment, pressure sensor 1120 comprises a wireless
pressure sensor provided by CardioMEMS, Inc. of Atlanta, Ga.,
though a suitable MEMS pressure sensor may be obtained from any
other source, including but not limited to Integrated Sensing
Systems (ISSYS), and Remon Medical. In one example, MEMS pressure
sensor 1120 comprises a pressure sensor described in U.S. Pat. No.
6,855,115, the disclosure of which is incorporated by reference
herein for illustrative purposes only. It will also be appreciated
that suitable pressure sensors may include, but are not limited to,
capacitive, piezoresistive, silicon strain gauge, or ultrasonic
(acoustic) pressure sensors.
It will be appreciated that pressure sensor 1120 may be configured
to wirelessly communicate pressure data to an external telemetry
device using a variety of structures and techniques. By way of
example only, telemetry may be provided using RF, ultrawideband
(UWB), ultrasonics, or any other suitable way of communicating. It
will also be appreciated that any protocol (e.g., Bluetooth, etc.)
within any modality of communication may be used. Accordingly,
pressure sensor 1120 may comprise a telemetry component (e.g., a
coil, a transmitter, etc.), or may be in communication with another
telemetry component (e.g., coil 114). To the extent that a
telemetry component of pressure sensor 1120 is unable to reach a
telemetry device external to patient 34 without some assistance,
such assistance may provided by any suitable number of relays (not
shown) or other devices.
It will also be appreciated that sensor system 1088 depicted in
FIG. 9 may provide functionality similar to internal control module
132 described above and depicted in FIG. 6. For instance, coil 114
of sensor system 1088 may be configured and operable in a manner
similar to TET/telemetry coil 156 of internal control module 132.
Similarly, pressure sensor 1120 of sensor system 1088 may be
configured and operable in a manner similar to pressure sensor 84
of internal control module 132. In addition, microcontroller 106 of
sensor system 1088 may be configured and operable in a manner
similar to microcontroller 106 of internal control module 132.
Other ways in which internal control module 132 components
illustrated in FIG. 6, or variations of such components, may be
incorporated into sensor system 1088 will be apparent to those of
ordinary skill in the art.
While sensor system 1088 has been described herein as an exemplary
sensor system, it will be appreciated that any other type of sensor
system may be used in any suitable location. Suitable alternative
sensor systems, as well as other suitable sensor system locations
(e.g., somewhere external to an injection port), are described in
many of the various patents, patent applications, and patent
publications that have been referred to and incorporated by
reference herein. Still other sensor system variations will be
apparent to those of ordinary skill in the art. Furthermore, it is
contemplated that some alternative embodiments may lack a sensor
system altogether.
FIGS. 10-13 show an exemplary sense head 300, which is operable to
externally sense the location and orientation of port 42. Sense
head 300 of this example comprises a needle window 302, a set of
horizontal coils 304, a set of vertical coils 306, a TET coil (not
shown), and a cable 310. The TET coil is wrapped around a generally
triangular bobbin (not shown), though any other configuration may
be used. In the present example, the TET coil is tuned in parallel
with a low ESR capacitor at 50 kHz to form a parallel tuned tank
circuit. Coil 114 of port 42 is tuned in series with capacitor 116
such that the resonant impedance is minimized at a resonant
frequency of 50 kHz. With an input power of 5 W on the TET coil,
coil 114 may deliver approximately 10 mW of power. Of course, any
other configurations and parameters may be used.
Each vertical coil 306 of sense head 300 is positioned
perpendicularly within a corresponding horizontal coil 304. While
three horizontal coils 304 and three vertical coils 306 are shown,
it will be appreciated that any suitable number of coils 304, 306
may be used. In addition, while the coils 304, 306 are shown as
being in a generally triangular arrangement, it will be appreciated
that any other suitable arrangement or configuration may be used.
Cable 310 is in communication with coils 304, 306, and is further
in communication with a display device 350 as will be described in
greater detail below. Of course, sense head 300 may be in
communication with any other external device via wire, wirelessly,
or otherwise.
Sense head 300 of the present example is configured to communicate
with an injection port, such as injection port 42 by way of example
only. It will be appreciated that sense head 300 may communicate
with any other injection port or other device, including but not
limited to alternative ports described herein and variations
thereof. It will be understood, however, that with some
embodiments, the type or amount of metal within a port 42 may have
an adverse effect on operation of the port 42 and/or sense head
300. For instance, such effects may be in the form of undesirable
eddy currents, to the extent that eddy currents are undesirable. To
the extent that a metal port 42 housing provides undesirable
results it will be appreciated that a coil 114 may be positioned
outside of such metal and hermetically wired to a pressure sensor
87 or to other port components. However, such measures are not
necessary with port 42 of the present example.
In the present example sense head 300 is operable to provide power
to port 42 via the TET coil. Sense head 300 is also operable to
detect the position and orientation of port 42, as will be
described in greater detail below. Furthermore, sense head 300 is
operable to receive pressure data and other data communicated from
port 42 in a manner similar to pressure reading device 60,
described above. In other words, in one embodiment, sense head 300
provides the same functionalities and serves the same purposes as
pressure reading device 60 described above. For instance, a coil
within sense head 300 (e.g., any one or more of coils 304, 306) may
receive communications from coil 114 indicating pressure data
obtained by pressure sensor 1120. Sense head 300 may thus provide a
coil that is configured and operable like the telemetry coil 144
shown in FIG. 6 and described above. Alternatively, sense head 300
may lack such functionality, or may otherwise be used in a manner
that does not include receiving pressure data.
While location, orientation, and pressure-related communications
will be described in greater detail below, those of ordinary skill
in the art will appreciate that any other types of information may
be communicated between port 42 and sense head 300 in any other
suitable manner. It will also be appreciated that sense head 300
need not necessarily be used to obtain any or all of location,
orientation, and/or pressure-related communications.
In one exemplary use, sense head 300 is placed adjacent to a
patient 34 in a region generally near port 42. As will be described
in greater detail below, sense head 300 may be used to determine
the location and orientation of port 42, thereby permitting a user
to position sense head 300 directly over or sufficiently near port
42. When sense head 300 is so positioned, the user may insert a
needle 430 of syringe 400 through needle guide 302 of sense head
300 and reach septum 76 of port 42 on the first try. The user may
then use syringe 400 to adjust the pressure of fluid within
implanted portion 32.
With sense head 300 placed in an initial position, horizontal coils
304 are configured to sense an RF signal provided by coil 114 in
port 42. It will be appreciated that characteristics of such RF
signal may vary as a function of the position of sense head 300
relative to port 42. Display device 350, which will be described in
greater detail below with reference to FIGS. 20-23, may receive
indications of such RF signals from each horizontal coil 304, and
may process these signals through a logic operable to compare the
signal picked up at each horizontal coil 304. Sense head 300 may
thus be used to determine the position of port 42 through
triangulation. For instance, when sense head 300 is positioned
directly over port 42, the three received signals may have an
approximately equal amplitude, and a phase shift of approximately
zero. It will be appreciated, however, that it may not be possible
to position sense head 300 such that the RF signal sensed at each
horizontal coil 304 has equal amplitude and a zero phase shift
relative to the RF signal as sensed at the other horizontal coils
304. Accordingly, sense head 300 may be moved around adjacent
patient 34 until the differences between the amplitudes and phases
of the RF signals sensed at horizontal coils 304 are minimized.
As will be described in greater detail below, a display device 350
may further comprise a logic operable to provide a visual
representation to the user indicating the relative positioning of
sense head 300 and port 42, and further provide a particular
indication when sense head 300 is positioned directly over port
42.
Sense head 300 may further comprise a feature operable to visually
display location information. In the present example, sense head
300 comprises a plurality of LEDs 312, which are arranged in a
"plus sign"-like configuration. LEDs 312 may provide a visual
indication to the user as to the relative positioning of sense head
300 and port 42. In particular, lit LEDs 312 may represent position
of port 42 relative to sense head 300. For instance, if sense head
300 needs to be moved down and to the right in order to be
positioned directly over port 42, the right-most and lower-most
LEDs 312 may be lit. As sense head 300 is moved closer to being
located directly over port 42, LEDs may provide feedback indicating
such proximity as sense head 300 is moved, until the center LED 312
is lit to indicate that sense head 300 is positioned generally over
port 42. When the center LED 312 is lit, the user may then desire
to refer to display device 350, as will be described in greater
detail below, to further adjust positioning of sense head 300. To
the extent that LEDs 312 are used, such LEDs 312 may be arranged in
any suitable configuration other than a "plus sign." Such
alternative configurations may comprise a Cartesian representation,
a polar representation, a numerical representation, or any other
type of representation. By way of example only, a star or compass
rose configuration may be used. In another embodiment, an array of
LEDs 312 are provided, and are operable to be selectively lit in
the form of an arrow indicating direction. The length of such an
arrow may further be varied to indicate distance. It will also be
appreciated that additional LEDs 312 may be used to increase
spatial resolution of distance and/or direction indicated by such
LEDs 312. Of course, any suitable alternative to LEDs 312 may be
used, including but not limited to an LCD screen or other display.
Alternatively, a sense head 300 may lack LEDs 312 or any substitute
therefor.
In one embodiment, a logic configured to process signals received
by horizontal coils 304 to provide positioning feedback through
LEDs 312 resides within sense head 300. In another embodiment, such
logic resides in display device 350, and is communicated to LEDs
312 in part through cable 310. In still another embodiment, the
logic for driving LEDs 312 resides within both sense head 300 and
display device 350. Still other suitable locations for logic to
drive LEDs 312, and other ways in which LEDs 312 may be driven,
will be apparent to those of ordinary skill in the art. It will
also be appreciated that, as with any other component and feature
described herein, LEDs 312 may simply be omitted altogether.
With sense head 300 placed in an initial position adjacent to a
patient 34 in a region generally near port 42, vertical coils 306
configured to sense an RF signal provided by coil 114 in port 42.
It will be appreciated that characteristics of such RF signal may
vary as a function of the orientation (e.g., pitch, yaw, roll,
attitude, etc.) of sense head 300 relative to port 42. Display
device 350 may receive indications of such RF signals from each
vertical coil 306, and may process these signals through a logic
operable to compare the signal picked up at each vertical coil 306.
When sense head 300 is oriented parallel with port 42, the three
received signals may have an approximately equal amplitude, and a
phase shift of approximately zero. As will be described in greater
detail below, display device 350 may further comprise a logic
operable to provide a visual representation to the user indicating
the relative orientation of sense head 300 and port 42, and further
indicate when sense head 300 is oriented substantially parallel
with port 42.
In another embodiment, sense head 300 and port 42 are configured
such that orientation characteristics may detected based on the
phase relationship between signals emitted by coil 114 and signals
from within sense head 300 (e.g., a launch/drive signal from a TET
coil in sense head 300). For instance, if the signals are in phase,
such a relationship may indicate that port 42 is oriented parallel
with sense head 300, and that septum 76 is facing sense head 300;
whereas the signals being 90.degree. out of phase may indicate that
port 42 is at approximately a 45.degree. to 90.degree. angle with
respect to sense head 300; while the signals being 180.degree. out
of phase may indicate that port 42 is approximately flipped over
relative to sense head 300 (e.g., septum 76 is facing inward within
patient 34). When port 42 is oriented at an angle of about
90.degree. relative to sense head 300, the phase difference may
abruptly flip between the signals being substantially in phase to
the signals being substantially out of phase. Other orientations
may be detected based on other corresponding phase relationships.
The phase relationship of signals may be compared using any
suitable logic (e.g., microprocessor, etc.) in any suitable
location (e.g., within sense head 300, within display device 350,
etc.).
In some embodiments, it may be desirable to position sense head 300
directly over port 42, if possible, to determine the orientation of
port 42. In particular, in some embodiments, if sense head 300 is
too far from being over the center of port 42, it may not be
possible to obtain signals emitted by port 42, or the results may
otherwise be unsatisfactory or untrustworthy. Accordingly, there
may be a target boundary around a location that is approximately
over the center of port 42, within which it may be desirable to
position sense head 300 to determine port orientation 42 in some
embodiments. By way of example only, a position that is
approximately over the center of port 42 may be located using sense
head 300 in a manner as described herein. Alternatively, the center
of port 42 may be approximately located simply by palpation or
using some other device or technique. Such alternatives may be
desirable where sense head 300 has only a single coil, or where
sense head is not able to detect the location of port 42. Other
ways in which the center of port 42 may be located will be apparent
to those of ordinary skill in the art. In other embodiments, the
center of port 42 need not be approximately determined in order for
port orientation 42 to be determined.
It will be appreciated that port 42 orientation information may be
obtained by moving sense head 300 within a boundary over the
approximate center of port 42. For instance, in some embodiments,
where coil 114 in port 42 is at some angle other than approximately
0.degree. or approximately 180.degree. relative to a coil in sense
head 300, the phase of the signals may change significantly as
sense head 300 is moved away from a position that is over the
approximate center of port 42. By contrast, where coil 114 in port
42 is at approximately 0.degree. or approximately 180.degree.
relative to a coil in sense head 300, the change in the phase of
the signals may be minimal as sense head 300 is moved away from a
position that is over the approximate center of port 42.
Furthermore, if coil 114 in port 42 is between approximately
0.degree. and approximately 45.degree. relative to a coil in sense
head 300, then the signals may remain substantially in phase as
sense head 300 is moved away from a position that is over the
approximate center of port 42; whereas the signals may be either
out of phase or switch between being in phase and out of phase as
sense head 300 is moved away from a position that is over the
approximate center of port 42 when coil 114 in port 42 is at an
angle that is greater than approximately 45.degree. relative to a
coil in sense head 300.
In some embodiments, it may be desirable to compare the phase of
the signals when the sensed amplitude of the signals is at a
maximum. Furthermore, where coil 114 in port 42 is at some angle
other than approximately 0.degree. or approximately 180.degree.
relative to a coil in sense head 300, the sensed amplitude of the
signal from coil 114 may be at its highest when sense head 300 is
positioned on the side or region that port 42 is facing.
Accordingly, where a non-zero angle of port 42 tilt is determined
using any technique, the angle at which port 42 is facing may be
determined by moving sense head 300 within a region around a
position that is approximately over the center of port 42 until the
maximum signal amplitude is measured.
Accordingly, it will be appreciated that orientation of port 42 may
be determined based upon changes in phase relationships and/or
amplitude as sense head 300 is moved within a boundary over the
approximate center of port 42, in addition to or as an alternative
to determining orientation simply by comparing a phase relationship
when sense head 300 is located approximately over the center of
port 42. It will also be appreciated that a ratio may be used to
determine port 42 orientation. By way of example only, a suitable
ratio may be the percentage of maximum signal amplitude when the
signals are in phase to the maximum signal amplitude when the
signals are out of phase. Little or no phase change may be
interpreted to indicate that the coil 114 in port 42 is
substantially parallel to a coil in sense head 300 (e.g., which may
indicate that port 42 is "flat" and properly oriented); while a
significant phase change may be interpreted to indicate that coil
114 in port 42 is not "flat" or is "tilted," or that coil 114 in
port 42 is "flipped."
In some situations, a comparison of signals may reveal that port 42
is tilted relative to sense head 300, and that septum 76 may not be
reached by a needle inserted directly through needle window 302 of
sense head 300 when sense head 300 is placed flat against patient
34. In some such situations, sense head 300 may be tilted relative
to patient 34 until the signals are in phase, such that the tilt of
sense head 300 relative to the adjacent surface of patient 34 may
mimic the tilt of port 42. In other words, tilting of sense head
300 may cause the signals to be in phase when sense head 300 is
tilted to an orientation making sense head 300 substantially
parallel with port 42. In some such situations, where sense head
300 is tilted in a manner to orient sense head 300 substantially
parallel with port 42, a needle may then be inserted through needle
window 32 of sense head 300 to reach septum 76 of port 42.
Accordingly, sense head 300 may be used to not only determine a
proper insertion point for a needle, but also to determine a proper
insertion angle for a needle in certain situations.
By way of example only, a drive frequency of approximately 50 kHz
may be used when determining phase relationships to determine
orientation of port 42. Of course, any other suitable frequency or
frequencies may be used. By way of illustration, FIG. 14 shows a
curve 200 representing an RF signal in a coil in sense head 300,
and a curve 202 representing an RF signal emitted by coil 113 in
port 42. As shown in FIG. 14, the signals are approximately
180.degree. out of phase, which may indicate that port 42 is
flipped over relative to sense head 300 (e.g., septum 76 is facing
inward within patient 34). By contrast, FIG. 15 shows curve 200
representing an RF signal in a coil in sense head 300, and curve
202 representing an RF signal emitted by coil 114 in port 42,
representing with the signals being in phase. This may indicate
that port 42 is oriented parallel with sense head 300, and that
septum 76 is facing sense head 300. In other embodiments, a
different phase relationship may indicate a flipped port 42 or
parallel port 42. For instance, sense head 300 or port 42 may be
configured such that a flipped port 42 will provide a signal that
is in phase with signal in sense head 300; and such that the
signals are approximately 180.degree. out of phase when septum 76
is facing sense head 300. Interpretation of phase relationships may
therefore be dependent upon the orientation of coil 114 within port
42 or the orientation of a relevant coil within sense head 300.
It will be appreciated that any suitable number of coils within
sense head 300 may be used to compare the "external phase" of sense
head 300 with the "internal phase" of coil 114 in port 42. For
instance, the phase of a single coil within sense head 300 may be
compared with the phase of coil 114 in port 42. Alternatively, the
phase of a plurality of coils (e.g., three sets of coils 304)
within sense head 300 may be compared with the phase of coil 114 in
port 42.
In another embodiment, coil 114 in port 42 emits a pattern of
pulses when sense head 300 is passed over port 42, such as two
short pulses followed by a longer pulse (e.g., about 3-4% longer
than the short pulses) when port 42 is right side up. When port 42
is flipped 180.degree., the pattern may be reversed. By way of
illustration, FIG. 16 illustrates curve 204 representing a pulsed
reference signal, a curve 206 representing a signal emitted by a
port 42 that is right side up, and a curve 208 representing a
signal emitted by a port that is flipped 180.degree.. Sense head
300 may receive these signals, and sense head 300 or any other
device (e.g., display device 350, etc.) may process such signals,
such that the user may be provided with an audio or visual
indication relating to the orientation of port 42 as described in
greater detail below. Accordingly, it will be appreciated that
vertical coils 306 are not necessarily needed to obtain orientation
information, and that the phase of signals need not necessarily be
compared in order to obtain orientation information. It will also
be appreciated that, where a signal patterns are used to provide
orientation information, such patterns may come in any of a variety
of forms and may have any suitable durations.
In yet another embodiment, port orientation information is obtained
using an accelerometer, such as a tri-axis accelerometer 400 as
illustrated in FIGS. 17-19. In this example, accelerometer 400
comprises a mass 402 suspended by piezo-resistive doped silicone
beams 404 within a ring 406. Accelerometer 400 is positioned within
port 42, and is in communication with coil 114. Accelerometer 400
is therefore operable to communicate port orientation information
to sense head 300 via telemetry. In other embodiments,
accelerometer 400 may be located on port 42, elsewhere within
patient 34, and/or may be configured to communicate with sense head
300 or any other device using any other suitable telemetry
structures or techniques.
It will also be appreciated that, when piezo-resistive doped
silicon beams 404 are interfaced with appropriate signal
conditioning circuitry (not shown), an analog output voltage may be
provided that is proportional to the acceleration imparted on
accelerometer 400. For instance, in a stationary context, the
earth's gravity may be realized and reported as 1 g. The
orientation of accelerometer 400 may be determined by comparing a
gravitational signal obtained through accelerometer 400 to 1 g. The
gravitational signal obtained through accelerometer 400 may be a
function of the electro-resistive properties of silicon beams 404,
or of a change in the electro-resistive properties of silicon
beams. By way of example only, FIG. 18 depicts mass 402 of
accelerometer 400 undergoing an acceleration in a lateral
direction, which is sensed by a change in electro-resistive
properties in silicon beams 404 that is caused by deformation of
the silicon beams 404. Such acceleration may be realized when port
42 is tilted within patient 34. As another example, FIG. 19 depicts
mass 402 of accelerometer 400 undergoing an acceleration in a
vertical direction, which is sensed by another change in
electro-resistive properties in silicon beams 404 that is caused by
deformation of the silicon beams 404. Such acceleration may be
realized when port 42 is flipped within patient 34.
Suitable configurations for signal conditioning circuitry that may
be used with accelerometer 400 will be apparent to those of
ordinary skill in the art, as will other ways in which
accelerometer 400 may be used to obtain port 42 orientation
information.
In another embodiment, a tilt sensor 500 is used. An exemplary tilt
sensor 500 is illustrated in FIG. 20, in which arrow 502 represents
the direction of gravity. In this example, tilt sensor comprises a
switch (not shown) that is normally open when tilt sensor 500 is
vertical. As tilt sensor 500 is tilted (e.g., rotated relative to
arrow 502), the switch remains open until the degree of tilt passes
a predefined switch angle 504. After tilt sensor 500 has been
tilted past switch angle 504, the switch in tilt sensor 500 closes,
and remains closed as tilt sensor 500 continues to be tilted past
switch angle 504. Accordingly, the switch in tilt sensor 500
remains open while tilt sensor 500 is oriented within a first
angular range 506; and the switch in tilt sensor 500 is closed
while tilt sensor 500 is oriented within a second angular range
508. In one embodiment, tilt sensor 500 comprises a SQ-SEN6XX by
SignalQuest, Inc. of Lebanon, N.H. Of course, any other suitable
type of tilt sensor 500 may be used. It will also be apparent to
those of ordinary skill in the art that the normally open and
normally closed conditions may be reversed, and that the switch may
be designed to change from a closed or open state at any desired
switch angle 504 or angles. For example the switch may be normally
closed at tilt angles between approximately 0.degree. and
approximately +/-30.degree., and normally open at tilt angles
between approximately 180.degree. and +/-150.degree.. Other
suitable angular ranges 506, 508 and switch conditions for such
angular ranges 506, 508 will be apparent to those of ordinary skill
in the art.
Furthermore, a tilt sensor 500 may be incorporated directly into or
onto port 42, and may be in communication with coil 114 (e.g.,
directly, via some other component, or otherwise in communication
with coil 114). Tilt sensor 500 of the present example is therefore
operable to communicate port orientation information to sense head
300 via telemetry. In other embodiments, tilt sensor 500 may be
located elsewhere within patient 34, and/or may be configured to
communicate with sense head 300 or any other device using any other
suitable telemetry structures or techniques. Alternatively, tilt
sensor 500 may be used to obtain port 42 orientation information in
any other suitable fashion using any other suitable structures,
circuits, or techniques.
In yet another embodiment, an inclinometer (not shown), such as a
MEMS inclinometer by way of example only, is incorporated into port
42 for obtaining orientation information. Still other suitable
structures and techniques for determining port orientation
information (e.g., other than phase comparisons and/or an
accelerometer, inclinometer, tilt sensor, position sensitive
switch, etc.) will be apparent to those of ordinary skill in the
art.
While port orientation detection is discussed herein in the context
of a system that is operable to obtain pressure data, it will be
appreciated that the structures and techniques described herein for
determining port orientation need not necessarily be incorporated
into a system that is also operable to obtain pressure data. For
instance, pressure data may be essentially irrelevant in some
systems (e.g., drug infusion systems, etc.), while orientation of
an injection port (or the orientation of some other system
component) may be relevant. Accordingly, it is contemplated that
the structures and techniques described herein for determining port
orientation may also be used in systems where there is no sensing
of any type of pressure whatsoever. It is also contemplated that
the structures and techniques described herein for determining port
orientation may be incorporated into components other than
injection ports, and may be used to determine the orientation of
such non-port components. For instance, the phase of a signal
emitted by a coil about an implanted pressure sensor or other
implanted device may be compared with the phase of an external coil
to determine the orientation of the implanted pressure sensor or
other implanted device for any suitable purpose(s). Other ways in
which the orientation detection structures and techniques described
herein may be used in various structural contexts will be apparent
to those of ordinary skill in the art.
An alternative sense head 301 is shown in FIG. 21. In this
variation, needle window 303 is offset from the center of sense
head 301, but is otherwise configured similar to sense head 300.
Such an offset of needle window 303 may reduce the likelihood that
the housing of sense head 301 will physically interfere with
external anatomical structures of patient 34 where such
interference would otherwise create difficulties in positioning the
centered needle window 302 of sense head 300 over port 42. The
offset of needle window 303 as shown in FIG. 21 is merely
exemplary, and it will be appreciated that needle window 303 may be
located elsewhere (e.g., proximate to an edge or corner of the
housing of sense head 301, etc.). It will also be appreciated that,
with needle window 303 not being positioned at the center of sense
head 301, needle window 303 will not be positioned at the
collective center of the arrangement of horizontal coils 304 and
vertical coils 306. Nevertheless, coils 304, 306 may still be used
to determine the relative positioning of needle window 303 and port
42 using techniques similar to those employed with sense head 300.
For instance, a corrective constant (e.g., a vector) may be
factored into an algorithm used to process RF signals sensed by
coils 304, 306. Such a corrective constant may represent the
displacement (e.g., in terms of distance and direction) of needle
window 303 relative to the center of sense head 301 (or relative to
the center of the arrangement of coils 304, 306). Various ways in
which such a corrective constant may be factored into the algorithm
will be apparent to those of ordinary skill in the art.
By way of example only, the position of the center of sense head
301 relative to port 42 may first be found by comparing RF signals
(e.g., in terms of phase and amplitude) received by horizontal
coils 304 (thereby obtaining a "determined position"). The
corrective constant may then be added to that determined position
to further determine the position of needle window 303 relative to
port 42. Alternatively, the properties of RF signals received by
coils 304 may have one or more characteristic disparities (or one
or more characteristic disparity ranges) when needle window 303 is
positioned directly over port 42, such that the algorithm may treat
that disparity in a manner similar to the minimized phase and
amplitude differences of RF signals received by coils 304 in sense
head 300. In other words, the algorithm may treat such disparity as
a target to be reached. The characteristic disparities in the
properties of RF signals sensed by horizontal coils 304 when needle
window 303 is positioned directly over port 42 may be a function of
the displacement of the needle window 303 relative to sense head
301, such that the characteristic disparities may be predetermined.
Of course, any other techniques or structures suitable for
determining the position of needle window 303 relative to port 42
may be used.
FIG. 22 shows an exemplary display device 350 that is configured to
translate information communicated from the sense head 300 into
visual representations readable by a user. In the present example,
display device 350 is in communication with sense head 300 via
cable 310, but again, any alternative to cable 310 may be used.
Display device 350 further comprises a graphical display 354, which
includes a target display 360, and is illustrated in FIGS. 23-24.
The target display 360 of the present example includes a crosshairs
362 and an arrow indicator 364. The target display 360 of this
example is operable to render location and orientation information
relating to the location and orientation of sense head 300 relative
to port 42. In particular, the position of the tip 366 of arrow
indicator 366 relative to the center 364 of crosshairs 362 may
serve to indicate the position of needle window 302 relative to the
center of port 42 (e.g., septum 76). In other words, the center 364
of crosshairs 360 may represent the center of septum 76; with the
tip 366 of arrow indicator 366 representing needle window 302. The
positioning data may be refreshed at any suitable rate, such as in
approximate real-time, to provide the user location feedback via
targeting display 360. The user may thus move sense head 300 until
targeting display 360 indicates that the needle window 302 is
located directly over port 42.
Orientation data may be rendered via targeting display 360 in terms
of the tilt of arrow indicator 366. In other words, the direction
and amount of tilt of arrow indicator 366 may represent the
orientation of sense head 300 relative to port 42, such that arrow
indicator 366 pivots about its tip 366 to indicate such
orientation. As with positioning/location data, the orientation
data may be refreshed at any suitable rate, such as in approximate
real-time, to provide the user orientation feedback via targeting
display 360. To the extent that sense head 300 cannot be
satisfactorily oriented relative to port 42 (e.g., if port 42 has
flipped upside-down or on its side relative to the fascial plane of
patient), surgery may be required to re-orient port 42.
Furthermore, to the extent that indicating the orientation of port
42 with arrow indicator 366 is not feasible, any other suitable
type of indication may be used. For instance, a textual indication
may be provided (e.g., text indicating that that port is flipped
over 180.degree.), an indication may be audible (e.g. number,
frequency, or tone of beeps), or indication of port orientation may
be provided in any other suitable way.
FIG. 24 shows a view of display device 350 with a target display
360 indicating that the sense head 300 is positioned substantially
directly over port 42 and substantially parallel with port 42.
Accordingly, arrow indicator 366 is positioned over center 364 of
crosshairs 362, and pivoted upright (i.e., perpendicular to the
screen), such that only the tail 370 of arrow indicator 366 can be
seen. Such a display may indicate to the user that a needle 403
inserted straight into needle window 302 will successfully reach
septum 76 of port.
It will also be appreciated that further visual indication may be
given to a user to represent location and orientation information,
such as with the use of colors. For instance, in the targeting
display 360 shown in FIG. 23, the arrow indicator 366 may be shown
in red to indicate that insertion of needle 403 through needle
window 302 would not be appropriate (e.g., needle 403 would not
reach septum 76). By contrast, in the targeting display 360 shown
in FIG. 24, tail 370 of arrow indicator 366 may be shown in green
to indicate that insertion of needle 403 through needle window 302
would be appropriate (e.g., the needle would reach septum 76).
It will also be appreciated that sense head 300 need not be
perfectly parallel with port 42 in order to successfully pass
needle 403 through needle window 302 into septum 76. Accordingly,
display device 350 may provide an indication showing that needle
403 may successfully reach septum 76 through needle window 302,
despite a non-parallel orientation of sense head 300 relative to
port 42. For instance, such orientation may be indicated where tail
370 of arrow indicator 366 is within a particular ring of
crosshairs 362. Alternatively, such orientation may be indicated by
coloring arrow indicator 366 yellow or some other color. Still
other ways in which the sufficiency of a non-parallel orientation
may be indicated in target display 360 will be apparent to those of
ordinary skill in the art.
Similarly, there may be a situation in which sense head 300 cannot
be located directly over port 42 without having unsatisfactory
orientation of sense head 300 relative to port 42; while sense head
300 may be oriented generally parallel with port 42 when not
positioned directly over port 42. In some such situations, the
septum 76 may nevertheless be reached by needle 403 inserted
through needle window 302 if needle 403 is oriented properly with
respect to sense head 300 (e.g., at an angle of approximately
80.degree. or a 10.degree. deflection). Accordingly, display device
350 may provide an indication showing that needle 403 may
successfully reach septum 76 through needle window 302, despite
sense head 300 not being positioned directly over port 42. For
instance, such orientation may be indicated where tail 370 of arrow
indicator 366 is within a particular ring of crosshairs 362.
Alternatively, such orientation may be indicated by coloring arrow
indicator 366 yellow or some other color. Still other ways in which
the sufficiency of an indirect sense head 300 location may be
indicated in target display 360 will be apparent to those of
ordinary skill in the art.
It will also be appreciated that sense head 300 may be configured
to obtain depth data indicating the distance from needle window 302
to port 42 (and, hence, depth to septum 76). Such depth data may be
represented on display device 350 in a variety of ways. For
instance, the depth may be indicated as a numerical value and/or in
any other suitable way. In addition to location, orientation, and
depth-related information, other geometric information that may be
obtained by sense head 300 and communicated to display device 350
will be apparent to those of ordinary skill in the art.
In addition to displaying information relating to the location and
orientation of sense head 300 relative to port 42, display device
350 may also display pressure data communicated from port 42 to
sense head 300. Accordingly, display device 350 of the present
example comprises a pressure display portion 374. As shown,
pressure display portion 374 provides an initial pressure reading,
a baseline pressure, and a peak pressure. The initial pressure
reading represents the pressure within implanted portion 32 before
fluid is added or withdrawn. The baseline pressure reading
represents the current pressure within implanted portion 32 (e.g.,
as fluid is being added or withdrawn or after fluid has been added
or withdrawn). The peak pressure reading represents the peak
pressure sensed during peristaltic motion of the stomach. Of
course, any other pressure parameters may be displayed, as may
other data such as temperature, etc. It will therefore be
appreciated that, in one embodiment, display device 350 provides
the similar functionalities and serves similar purposes as display
66 described above.
As noted above, sense head 300 may be configured to receive
pressure data from port 42 in a manner similar to pressure-reading
device 60. It will therefore be appreciated that the TET coil of
sense head 300 may also serve as a telemetry coil to receive
telemetry signals from coil 114 in port 42 indicating pressure or
other data. Alternatively an additional coil dedicated to such
telemetry may be provided in sense head 300. As yet another
variation any of vertical coils 306 and/or horizontal coils 304 may
be used for such telemetry. Still other suitable configurations
will be apparent to those of ordinary skill in the art.
In view of the foregoing, it will be appreciated that sense head
300 and display device 350 may be used to provide approximately
real-time pressure measurements to a user before, during, and after
the addition or withdrawal of fluid to or from implanted portion
32. For instance, a surgeon may adjust the saline content of
implanted portion 32 while patient 34 swallows a fixed amount of
water, and may monitor the pressure level in implanted portion via
sense head 300 and display device 350 during such activities. It
will be appreciated that an optimal pressure adjustment may be
determined based on a variety of factors related to pressure data,
including but not limited to any of the following: the original
baseline pressure; the new baseline pressure; the maximum
peristaltic pressure; the minimum peristaltic pressure; the length
of a peristaltic contraction; the Fourier transform of a
peristaltic contraction data spike; the pressure decay time
constant during persistaltic contractions; the total averaged
pressure decay time constant during a water swallowing period; the
number of peristaltic contractions to swallow a fixed amount of
water; one or more forces exerted by an implanted device and/or an
anatomical structure; energy of an implanted device or of fluid
therein; the fill rate of fluid into an implanted device; the
volume of fluid in an implanted device; the capacity of an
implanted device; the flow rate of fluid into or within an
implanted device; the pressure pulse rate of fluid within an
implanted device; a counted number of pressure pulses of fluid
within an implanted device; one or more electrical signals
communicated from tissue prior to and/or in response to adjustment
of an implanted device; chemical(s) output from tissue prior to
and/or in response to adjustment of an implanted device; other
tissue feedback responsive to adjustment of an implanted device; or
any other factors.
In one embodiment, display device 350 is operable to receive data
indicative of the above-noted factors in any suitable fashion
(e.g., from sensors, etc.), and is further operable to
automatically process such factors and present the result of such
processing to the user. For instance, display device 350 may be
configured to determine an ideal amount of fluid to be added or
withdrawn based on such processing of factors, and may simply
display a message to the user such as "Add 4 cc's of fluid,"
"Withdraw 0.5 cc's of fluid," or the like. Such messages may be
displayed in addition to or in lieu of displaying pressure
measurements, changes in pressure, or other data. Other suitable
processes of any of the above-noted factors or other factors, as
well as ways in which results of such processes may be presented to
the user, will be apparent to those of ordinary skill in the
art.
In the present example, pressure sensor 84 provides pressure data
at an update rate of approximately 20 Hz. Such a rate may provide a
telemetry/TET mode cycle completion at approximately every 50 ms.
For instance, coil 114 may provide TET for port 42 for
approximately 45 ms to power port 42, then provide telemetry of
pressure data for approximately 5 ms. Of course, any other
switching topology may be used. It will also be appreciated that
switching between TET and telemetry may be unnecessary. For
instance, port 42 may be active, such that TET is not required. As
another example, a second coil (not shown) may be added to port 42,
with one of the coils in port 42 being dedicated to TET and the
other to telemetry. Still other alternatives and variations will be
apparent to those of ordinary skill in the art.
While display device 350 of the present example shows pressure data
being represented numerically, it will be appreciated that pressure
data may be represented in a variety of other ways. For instance, a
graph may show pressure as a function of time, which may be useful
for monitoring pressure during peristaltic activity or for other
purposes.
By way of example only, FIG. 25 is a graphical representation of a
pressure signal 216 from the pressure sensing system of the
invention, such as may appear on display device 350 or some other
display 66 during interrogation by a user. In the example shown in
FIG. 25, the fluid pressure is initially obtained by pressure
sensor 1120 in communication with sense head 300 via coil 114 while
the patient is stable, resulting in a steady pressure reading as
shown. Next, an adjustment is applied to band 38 to decrease the
stoma size. During the band adjustment, the pressure sensing system
1088 continues to measure the fluid pressure and transmit the
pressure readings through the patient's skin to sense head 300. As
seen in the graph of FIG. 25, the pressure reading rises slightly
following the band adjustment. In the example shown, the patient is
then asked to drink a liquid to check the accuracy of the
adjustment. As the patient drinks, the pressure sensing system
continues to measure the pressure spikes due to the peristaltic
pressure of swallowing the liquid, and transmit the pressure
readings to display device 350 for display.
It will also be appreciated that absolute values of pressure at
particular moments in time need not be displayed, and that display
device 350 may instead display changes in pressure value. Other
ways in which pressure data or other data may be displayed will be
apparent to those of ordinary skill in the art.
As discussed above, it may be desirable to account for temperature,
atmospheric pressure, and other factors when considering
measurements of pressure within implanted portion 32. Accordingly,
sense head 300 may receive additional data such as temperature
measurements taken within implanted portion 32, and display device
350 may comprise logic configured to adjust pressure readings in
accordance with a variety of such factors.
By measuring and visually depicting the loading of the restriction
device against the peristaltic motion of the stomach both during
and after an adjustment, a physician may be provided with an
accurate, real-time visualization of the patient's response to the
adjustment. This instantaneous, active display of recorded pressure
data may enable the physician to perform more accurate band
adjustments. The data may be displayed over time to provide a
pressure verses time history.
In addition to use during adjustments, a pressure sensing system
may also be used to measure pressure variations in a restriction
device at various intervals during treatment. Periodic pressure
readings may enable a pressure sensing system to function as a
diagnostic tool, to ensure that the food intake restriction device
is operating effectively. In particular, a pressure sensing system
may be utilized to detect a no pressure condition within the band,
indicating a fluid leakage. Alternatively, the system may be used
to detect excessive pressure spikes within the band, indicating a
kink in catheter 44 or a blockage within the stoma.
A pressure sensing system may also enable a patient to track their
own treatment, utilizing an external monitor, such as external
device 36, at home. Using the external device, the patient may
routinely download pressure readings to their physician's office,
thereby reducing the number of office visits required to monitor
the patient's treatment. Additionally, the patient could perform
pressure readings at home and notify their physician when the band
pressure drops below a specified baseline or exceeds a threshold,
indicating the need for an adjustment of the device. A pressure
sensing system may thus have benefits as both a diagnostic and a
monitoring tool during patient treatment with a bariatric
device.
In one version, sense head 300 comprises a switch (not shown) which
is operable to switch sense head 300 between a positioning mode and
a pressure sensing mode. Thus, the user may switch sense head 300
to positioning mode to obtain location and orientation data to
sufficiently position sense head 300 over port 42. The user may
then switch sense head 300 to pressure sensing mode to obtain
pressure measurements before, during, and after the addition or
withdrawal of fluid to or from implanted portion 32. Alternatively,
a similar switch may be provided on display device 350. In yet
another version, no switch is used, such that sense head 300 is
operable for use in a positioning mode and pressure sensing mode
simultaneously. Still other possible modes and features for
effecting switching between such modes will be apparent to those of
ordinary skill in the art.
It will also be appreciated that sense head 300 may be used in
conjunction with a port that has a coil but lacks a pressure
sensor. In other words, sense head 300 may be used simply to
determine the location and/or orientation of a port. Upon such a
determination, pressure data may be obtained from a source other
than the port (e.g., from a sensor elsewhere in implanted portion,
from a sensor external to the patient, etc.) or not be obtained at
all. Other suitable methods and devices for obtaining pressure data
are disclosed in U.S. Non-Provisional application Ser. No.
11/668,122, entitled "External Mechanical Pressure Sensor for
Gastric Band Pressure Measurements," filed Jan. 29, 2007, the
disclosure of which is incorporated by reference herein; U.S.
Non-Provisional application Ser. No. 11/673,642, entitled
"Apparatus for Adjustment and Sensing of Gastric Band Pressure,"
filed Feb. 12, 2007, the disclosure of which is incorporated by
reference herein; and U.S. Non-Provisional application Ser. No.
11/682,459, entitled "Pressure Sensors for Gastric Band and
Adjacent Tissue," filed Mar. 6, 2007, the disclosure of which is
incorporated by reference herein.
It will also be appreciated that a plurality of pressure sensors
may be used, including but not limited to several pressure sensors
within a port and/or located elsewhere. For instance, a gastric
band system may comprise a pressure sensor within a gastric band 38
in addition to a pressure sensor within a catheter 44 that is in
fluid communication with band. Such a plurality of pressure sensors
may provide an indication of how well fluid pressure is distributed
among components of a gastric band system. Such a plurality of
pressure sensors may also provide greater accuracy in pressure
readings, reduce the likelihood of catheter obstruction (e.g.,
pinching) affecting pressure reading, may reduce effects of
hydrostatic pressure changes from patient movement, or may provide
a variety of other results. It will also be appreciated that any
system that includes a plurality of pressure sensors may include a
pressure sensor in a port 42 and/or a pressure sensor external to
patient 34 (e.g., a pressure sensor in a syringe and/or a pressure
sensor portion coupled with a syringe), in addition to any of the
internal pressure sensors described above. Still other structures
and techniques suitable for sensing or measuring pressure, and
locations for sensing or measuring pressure, will be apparent to
those of ordinary skill in the art. The particular structures and
techniques described herein for sensing or measuring pressure are
not deemed critical, and the inventors contemplate that any
suitable structures, techniques, and locations for measuring
pressure may be used.
In addition to sensing pressure of fluid within implanted portion
32 as described in various embodiments above, it will be
appreciated that pressure of fluid within esophagus 48, upper pouch
50, and/or stomach 40 may also be sensed using any suitable device,
such as an endoscopic manometer. By way of example only, such fluid
pressure measurements may be compared against measured pressure of
fluid within implanted portion 32 before, during, and/or after
adjustment of pressure within implanted portion 32. Other suitable
uses for measured pressure within esophagus 48, upper pouch 50,
and/or stomach 40 will be apparent to those of ordinary skill in
the art.
Furthermore, a device such as an internal or external inclinometer
(or a substitute therefor) may be used to determine the angle at
which patient 34 and/or implanted portion 32 is oriented (e.g.,
standing, lying down, etc.), which may be factored into pressure
data sensed by one or more sensors to account for hydrostatic
pressure effects caused by a patient's 34 orientation. Such a
factor (or any other factor) may be accounted for prior to or in
conjunction with the rendering of a pressure reading.
It will become readily apparent to those skilled in the art that
the above invention has equally applicability to other types of
implantable bands. For example, bands may be used for the treatment
of fecal incontinence. One such band is described in U.S. Pat. No.
6,461,292, which is hereby incorporated herein by reference. Bands
may also be used to treat urinary incontinence. One such band is
described in U.S. Pub. No. 2003/0105385, which is hereby
incorporated herein by reference. Bands may also be used to treat
heartburn and/or acid reflux. One such band is described in U.S.
Pat. No. 6,470,892, which is hereby incorporated herein by
reference. Bands may also be used to treat impotence. One such band
is described in U.S. Pub. No. 2003/0114729, which is hereby
incorporated herein by reference. Other suitable types of and uses
for implantable bands will be apparent to those of ordinary skill
in the art.
While the present invention has been illustrated by description of
several embodiments, it is not the intention of the applicant to
restrict or limit the spirit and scope of the appended claims to
such detail. Numerous other variations, changes, and substitutions
will occur to those skilled in the art without departing from the
scope of the invention. For instance, the device and method of the
present invention has been illustrated in relation to providing a
pressure sensor within the injection port. Alternatively, a sensor
could be positioned within a fluid filled portion of the band in
order to measure pressure changes within the band. Additionally, a
pressure sensor could be associated with an elastomeric balloon
implanted within the stomach cavity to measure fluid pressure
within the balloon. A pressure sensor could also be associated with
a device external to a patient (e.g., as part of a syringe
assembly), or could be provided in any other suitable location. The
structure of each element associated with the present invention can
be alternatively described as a means for providing the function
performed by the element. It will be understood that the foregoing
description is provided by way of example, and that other
modifications may occur to those skilled in the art without
departing from the scope and spirit of the appended Claims.
* * * * *
References